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Webinars

Advancing precision immunotherapy through next-generation sequencing of T cell receptors: Part I
ADVANCING PRECISION IMMUNOTHERAPY THROUGH NEXT-GENERATION SEQUENCING OF T CELL RECEPTORS: PART I
This webinar will review recent advancements in the application of next-generation sequencing of T cell receptor beta (TCRB) chain repertoires towards predictive and mechanistic biomarker discovery for cancer immunotherapy. Dr. Looney will focus on immunotherapy biomarker applications of a long-ampl...

Precision Medicine 2018
PRECISION MEDICINE 2018
Our 3rd Annual Precision Medicine Virtual Conference is now available On Demand! Precision Medicine 2018 will continue the dialogue and provide updates on new efforts in drug discoveries, developments in FDA regulatory structures, and the integration of genetics on disease progression. Precision Med...

CRISPR for Disease Detection and the Future of Accessible Healthcare
CRISPR FOR DISEASE DETECTION AND THE FUTURE OF ACCESSIBLE HEALTHCARE
This webinar explores the technology behind Mammoth Biosciences’ newly announced CRISPR-powered diagnostics platform, giving insight to CRISPR and how it works for disease detection. In this webinar, Ashley will first give an explanation of what CRISPR does and how it’s been used up unti...

Exon-level array: Bridging the gap between chromosomal microarray and next-gen sequencing
EXON-LEVEL ARRAY: BRIDGING THE GAP BETWEEN CHROMOSOMAL MICROARRAY AND NEXT-GEN SEQUENCING
Current exon-level arrays and NGS techniques for CNV detection are plagued with a high number of false-positive calls and are challenging from a cost perspective when verifying numerous exon aberrations with orthogonal methods. Relevant gene lists continue to grow such that custom del/dup arrays out...

Using bioactivity profiling to support the progression of phenotypic hits
USING BIOACTIVITY PROFILING TO SUPPORT THE PROGRESSION OF PHENOTYPIC HITS
Bioactivity profiling has been traditionally used to assess the selectivity of new drug candidates in the context of target-based approaches, where pharmacological selectivity is a key requirement. Phenotypic screening provides hit molecules where the only initial constraint is activity in a functio...

The Neuroscience of Body Clocks (Online Symposium)
THE NEUROSCIENCE OF BODY CLOCKS (ONLINE SYMPOSIUM)
This online symposium will explore the neuroscience underpinning the daily rhythms of the brain. Specifically, the event will focus on the neurobiology of circadian rhythms, our 24-hour sleep/wake cycle. Leading researchers will discuss their work investigating the neural circuitry that wakes us up ...

Sequence Your Biopharma N-Glycans in as Little as 1 Hour
SEQUENCE YOUR BIOPHARMA N-GLYCANS IN AS LITTLE AS 1 HOUR
If you are working with N-linked carbohydrates of glycoproteins in the biopharmaceutical or biomedical fields, imagine the amount of time you can save with either semi- or fully-automated CE methods providing you information in just 60-120 minutes. Comprehensive analysis of the N-linked carbohydrate...

Automated assessment of Liver and Cardiac toxicities in lead optimisation, using biochemical and human iPS cell assays
AUTOMATED ASSESSMENT OF LIVER AND CARDIAC TOXICITIES IN LEAD OPTIMISATION, USING BIOCHEMICAL AND HUMAN IPS CELL ASSAYS
In this two-part webinar, both automation of P450 (CYP) assays and the automatization of cellular differentiation processes and compound testing using human induced pluripotent stem cells based assays was covered.  Metabolism of drugs is a key factor in compound toxicity, and automated assays w...

How to make digital work in medtech
HOW TO MAKE DIGITAL WORK IN MEDTECH
The rise of mobile devices and apps, not to mention the involvement of non-medical technology players, is creating a wave of irrevocable digital change for medtech.
It’s transforming how the sector reaches and engages with its stakeholders and customers, and in doing so provides vital o...

Investigating the role of microRNAs in pancreatic cancer progression
INVESTIGATING THE ROLE OF MICRORNAS IN PANCREATIC CANCER PROGRESSION
Pancreatic ductal adenocarcinoma (PDAC) is a deadly disease with a 5-year survival rate of approximately 6%. Despite recent efforts in developing novel therapies, chemotherapy remains the standard of care for advanced pancreatic cancer patients. MicroRNAs (miRNAs) are short non-coding RNAs that act ...

CANCER IMMUNOTHERAPY: EXPERIMENTAL MODELS AND APPROACHES
CANCER IMMUNOTHERAPY: EXPERIMENTAL MODELS AND APPROACHES
The mammalian immune system has developed surveillance mechanisms that can detect cancerous cells. However successful tumor cells have evolved strategies to evade detection. Current therapeutic strategies focus on improving cancer cell recognition and tumor elimination. Both immunocompetent and immu...

Diagnostic and Therapeutic Patent and License Strategies
DIAGNOSTIC AND THERAPEUTIC PATENT AND LICENSE STRATEGIES
Dr. Lisa Haile presents this webinar exploring issues and strategies for diagnostic and therapeutic patents and licenses. This webinar will address questions such as: Are diagnostic tests patentable? What are the effects of the Alice ruling and the Myriad Genetics case on patents? What strategies ca...

Raman spectroscopy measurements during Bioprocessing
RAMAN SPECTROSCOPY MEASUREMENTS DURING BIOPROCESSING
Raman spectroscopy has been seen as the spectroscopic tool used in bioprocessing to monitor and control cell metabolism to optimize quality and yield of titer. This is due to Raman’s insensitivity to water and the ability to analyze samples without manipulation. However, there are certain chal...

Development and Manufacturing of Recombinant Nanoparticle Vaccines
DEVELOPMENT AND MANUFACTURING OF RECOMBINANT NANOPARTICLE VACCINES
A recombinant vaccine technology platform based on highly purified, properly-folded protein antigens in stable well-defined Nanoparticles, enabling the efficient and safe manufacture of vaccines against highly pathogenic targets. Nanoparticles are intrinsically immunogenic, producing both durable ne...

Fast and complete cyclic peptide metabolite detection and characterization by LC-MS
FAST AND COMPLETE CYCLIC PEPTIDE METABOLITE DETECTION AND CHARACTERIZATION BY LC-MS
Cyclic peptides have emerged as next-generation therapeutic agents, due to their unique structure and potential biological function. However, the study of cyclic peptide drug metabolism by LC-MS is challenging because these therapeutics typically d...

EFIRM Liquid Biopsy (eLB)
EFIRM LIQUID BIOPSY (ELB)
The advent of personalized medicine employing molecularly targeted therapies has markedly changed the treatment of cancer in the past decade. The liquid biopsy is a rapidly emerging field to address this unmet clinical need as diagnostics based on cell-free circulating tumor DNA (ctDNA) can be a sur...

Optimised genome editing of PSCs enabling efficient production of disease models
OPTIMISED GENOME EDITING OF PSCS ENABLING EFFICIENT PRODUCTION OF DISEASE MODELS
Therapeutic development for human diseases continues to face obstacles, particularly in translating targets or compounds identified by in vitro screening campaigns to valid targets or efficacious and safe compounds once tested in humans. Here we discuss strategies that leverage induced pluripotent s...

Legal Aspects in Representing Clients With Dementia
LEGAL ASPECTS IN REPRESENTING CLIENTS WITH DEMENTIA
Whenever individuals or their families are faced with a medical diagnosis of dementia, they are confronted with daunting questions--how to provide for care when the patient can no longer manage his or her own affairs, what to do to protect their rights and property, and how to cope with the day-to-d...

Freeze Drying Solutions For Your Lab
FREEZE DRYING SOLUTIONS FOR YOUR LAB
Does your work require you to freeze dry samples? Are your results inconsistent? Is your freeze dry cycle taking too long? Learn how to optimize your lyophilization process. This webinar will discuss freeze-drying techniques, as well as new accessories and advancements in laboratory freeze dryers th...

Making Polychromatic Flow Cytometry easy after Instrument Characterization and Validation
MAKING POLYCHROMATIC FLOW CYTOMETRY EASY AFTER INSTRUMENT CHARACTERIZATION AND VALIDATION
Polychromatic flow cytometry is a powerful tool in measuring and quantitating the expression of numerous antigens present on a single cell. Different instrument configurations or instruments with similar configurations can result in varied results with some populations not being easily resolved. In ...

Understanding Guidance and Recommendations for Medical Device Cybersecurity
UNDERSTANDING GUIDANCE AND RECOMMENDATIONS FOR MEDICAL DEVICE CYBERSECURITY
Medical devices have become content rich, interconnected technology. But as their technology grows, so does the risk of exploitation and cyber threats, exposing medical devices as a potential target for cybercriminals to obtain information from healthcare organizations and their patients. With ...

Transforming Access to Medicines Through Patient-Centric Solutions
TRANSFORMING ACCESS TO MEDICINES THROUGH PATIENT-CENTRIC SOLUTIONS
As medicines access evolves and pharmaceutical companies take an increasingly nuanced approach to it, it’s ever-more important to focus on particular aspects of this area and investigate whether firms are operating optimally. To do this Inceptua Medicines Access and patient group, HAEi, in ass...

Continuous Processing in Biomanufacturing: Considerations for Adoption and Case Studies in Biologic Development and Manufacturing
CONTINUOUS PROCESSING IN BIOMANUFACTURING: CONSIDERATIONS FOR ADOPTION AND CASE STUDIES IN BIOLOGIC DEVELOPMENT AND MANUFACTURING
As the biologics industry continues to grow, biopharmaceutical companies are evaluating continuous processing as a potential means to improve efficiencies. There are many factors to consider when determining whether continuous processing should be adopted, and if so, what adoption strategy should be...

Fully continuous biosimilar manufacturing frameworK
FULLY CONTINUOUS BIOSIMILAR MANUFACTURING FRAMEWORK
Biologics manufacturing has traditionally been in a fed-batch mode for the last 2 decades. During the early stages of biologics manufacturing, lower cell line productivity and product instability necessitated the usage of perfusion technology. As productivity increased and maps became more stable, p...

Spotlight on Sickle Cell Disease
SPOTLIGHT ON SICKLE CELL DISEASE
Devin and Jason McCourty, football players and sickle cell disease advocates, teamed up with Novartis to host a Facebook Live event to raise awareness of the social and emotional impact of sickle cell disease. They joined a panel including patient KC Morse and physician expert Dr. Andemariam.

Acute Coronary Syndrome: Getting to the Heart of the Matter for Pharmacists
ACUTE CORONARY SYNDROME: GETTING TO THE HEART OF THE MATTER FOR PHARMACISTS
Acute coronary syndrome (ACS) is not just one disease but a group of disorders that can be thought of as a continuum of injury with the least severe being angina (UA), followed by non-ST elevation myocardial infarction (NSTEMI), and then the most severe, ST-elevation myocardial infarction (STEMI). A...

Drug development with nuclear receptor knockout and humanized rat models
DRUG DEVELOPMENT WITH NUCLEAR RECEPTOR KNOCKOUT AND HUMANIZED RAT MODELS
The nuclear receptors pregnane X receptor (PXR) and constitutive androstane receptor (CAR) are closely related transcription factors that regulate the expression of Phase I (Cytochrome P450s), Phase II drug metabolizing enzymes and drug transporter genes in response to stimulation from xenobiotics i...

Are Pharma Services Vendors Becoming Digital Health Agencies?
ARE PHARMA SERVICES VENDORS BECOMING DIGITAL HEALTH AGENCIES?
Despite the fact that there is little uniformity in the definition of "digital health," the interest in this sphere continues to grow rapidly.  Pharma services vendors are on the front lines of this movement and are increasingly being asked to perform functions that were not originall...

Multiplexed immunofluorescence and digital image analysis for clinical use
MULTIPLEXED IMMUNOFLUORESCENCE AND DIGITAL IMAGE ANALYSIS FOR CLINICAL USE
There is an ever-increasing need to understand the role of the Tumor Microenvironment (TME) in Cancer Immunotherapy. In this webinar, Drs. Lei Tang, Ph.D. and Mehrnoush Khojasteh, Ph.D. of Roche Tissue Diagnostics (Ventana Medical Systems, Inc.), present their work on multiplex immunofluorescence st...

The Rise of Digital Enterprise: Growth Strategies for Healthcare Companies
THE RISE OF DIGITAL ENTERPRISE: GROWTH STRATEGIES FOR HEALTHCARE COMPANIES
Digital Transformation is powering growth opportunities in Smart R&D, Patient Engagement, and Healthcare eCommerce. The explosion of patient centricity and technological advancement in big data analytics, cloud, and artificial intelligence are putting severe pressures on companies to leverage al...

What’s New in the World of Employment-Related Drug Testing?
WHAT’S NEW IN THE WORLD OF EMPLOYMENT-RELATED DRUG TESTING?
Attendees will learn about new OSHA requirements and walk away with best practices for handling issues related to legalized marijuana and prescription abuse in the workplace.

Patients as Partners: Imagining the Future of Rare Disease Therapies
PATIENTS AS PARTNERS: IMAGINING THE FUTURE OF RARE DISEASE THERAPIES
This is the first installment of our new webinar series, Healthy Opinions. It is now available to watch any time as an OnDemand resource. Healthy Opinions covers important topics in the life sciences industry. We feature top thought leaders and experts in a panel format. All panelists participate us...

Current and future applications of Near-infrared in Pharmaceutical and Biopharma
CURRENT AND FUTURE APPLICATIONS OF NEAR-INFRARED IN PHARMACEUTICAL AND BIOPHARMA
Near-infrared has a long tradition as analytical technology in pharmaceutical industry. In this article/webinar new applications, technology and improvements in regulatory guidances will be presented which will support further growth of nearinfrared in the pharmaceutical and biopharmaceutical indust...

UK pharma and integrated health
UK PHARMA AND INTEGRATED HEALTH
The concept of integrated healthcare is not new to the UK, where it has been discussed since the late 1960s.The difference is that now it could really happen. Technology, medicine, regulation and pricing have all evolved to a point where a collaborative, integrated system is not only possible, but d...

Improving outcomes through industry partnership - the Cancer Vanguard learnings
IMPROVING OUTCOMES THROUGH INDUSTRY PARTNERSHIP - THE CANCER VANGUARD LEARNINGS
The Cancer Vanguard is a bold initiative setup to take leadership in the delivery of the National Cancer Strategy  Achieving World-Class Cancer Outcomes published in 2015 with a key aim of designing and implementing new and increasingly patient centric models of care in Cancer that can benefit ...

Drug Trends and Pharmacy Benefit Strategies for 2018
DRUG TRENDS AND PHARMACY BENEFIT STRATEGIES FOR 2018
This one-hour webinar explored the impact of generic and specialty drugs (including biosimilars) on employer costs for 2018. Attendees heard about new drugs in the pipeline that employers should start thinking about from a coverage and cost standpoint. They also learned about plan design features em...

 Decoding Drug Resistance with Machine Learning and Systems Biology
DECODING DRUG RESISTANCE WITH MACHINE LEARNING AND SYSTEMS BIOLOGY
Learn how a systems biology approach that utilizes machine learning tools facilitates drug resistance discovery. Special guest, Cancer Biology PhD candidate Reema Baskar, co-mentored by Drs. Sean Bendall and Sylvia Plevritis of Stanford University, will show you how they leveraged Cytobank along wit...

Reducing efficacy-related failures with PharmaPendium
REDUCING EFFICACY-RELATED FAILURES WITH PHARMAPENDIUM
Join us for this 45-minute webinar that will include in-depth information and demonstrations of how to leverage the comparative data in PharmaPendium to reduce the risk of late-stage failures. With a focus on efficacy, we will discuss how PharmaPendium enables you to: find efficacy weaknesses early,...

Hot-Stage Microscopy
HOT-STAGE MICROSCOPY
Thermo-optical analysis (TOA) is a widely used technique, which can be combined with DSC. TOA permits visual observation of the physical changes in a sample as a function of temperature or time. Combined with DSC, heat flow can be simultaneously recorded for a more comprehensive analysis. In this we...

Earned Media Analytics for Pharma. Made Super Super Easy.
EARNED MEDIA ANALYTICS FOR PHARMA. MADE SUPER SUPER EASY.
The media has an insatiable appetite for stories about how science and discovery is saving, improving, and extending people's lives. Outreach, story development, case studies, content marketing, social media programs, etc. are critical to creating customer awareness and driving drug sales. Will ...

The Creative Debate: Why creativity is key to true patient centricity in pharma
THE CREATIVE DEBATE: WHY CREATIVITY IS KEY TO TRUE PATIENT CENTRICITY IN PHARMA
Meeting the needs of both patients, and healthcare professionals, in today's fast changing communications landscape can be challenging, particularly against the backdrop of compliance. Putting creativity at the heart of the process can be the most effective way of tackling these challenges. Alth...

Immuno-oncology
IMMUNO-ONCOLOGY'S EVOLUTION: IMPLICATIONS FOR PHARMA MARKET RESEARCHERS
Immuno-oncology therapies that harness the body’s own defences to fight tumours are widely acknowledged as the new frontier in cancer treatment, but until recently only a few products had reached the market for a limited number of indications. Over the past 12 months several new products have ...

Alternative Financing Models for Drug Development
ALTERNATIVE FINANCING MODELS FOR DRUG DEVELOPMENT
Watch this on-demand webinar with DocuSign and Xconomy to learn about the latest research on alternative financial models for drug development. You will also learn how you can speed up contract and approval cycles by using an eSignature solution for everything ranging from clinical trials to distrib...

Global R&D & Clinical Trends with Pharmaprojects
GLOBAL R&D & CLINICAL TRENDS WITH PHARMAPROJECTS' IAN LLOYD
To glean more data on what was outlined in this presentation download the latest copy of Pharmaprojects’ Pharma R&D Annual Review 2018 authored by Ian Lloyd at: http://bit.ly/2ufogGUFilmed at the Informa Tokyo Seminar. Ian Lloyd the Senior Director of Pharmaprojects and Data Integration, o...

Companion Diagnostics Webinar Recording
COMPANION DIAGNOSTICS WEBINAR RECORDING
Companion diagnostics are poised to be a huge growth area worldwide, with a CAGR of 20.1% over the next 5 years, making it a $6B industry by 2022.In this webinar recording our presenters will take a look across key trends for both device and drug companies and deliver insights to support your deal-m...

How Alembic Pharma secures & leverages email data with Vaultastic
HOW ALEMBIC PHARMA SECURES & LEVERAGES EMAIL DATA WITH VAULTASTIC
Alembic Pharmaceuticals Limited is a leading Indian Pharma company with a Global presence in 75 Countries & Representative Offices in 7 Countries. Watch this webinar to understand the fundamentals of email archiving and Ediscovery, and how Alembic Pharma used this to secure and leverage email. L...

Mastering mHealth Apps & Wearables to Improve Health Outcomes
MASTERING MHEALTH APPS & WEARABLES TO IMPROVE HEALTH OUTCOMES
The pharmaceutical industry has made great strides in adopting new technology tools such as social media and mobile apps to communicate with healthcare professionals, consumers, patients, policymakers, and payers. The next frontier is to master these tools in order to improve health outcomes. Topics...

Real Time Release Testing of Pharma Drug Products Full Webinar
REAL TIME RELEASE TESTING OF PHARMA DRUG PRODUCTS FULL WEBINAR
Real Time Release Testing of Pharmaceutical Drug Products: How Does Raman Measure Up?NIR spectroscopy is widely developed and implemented as a PAT measurement tool. NIR based assay of pharmaceutical solid dosages has been implemented for real time release testing of tablets. Considerable effort is r...

The Future of the Pharma Industry
THE FUTURE OF THE PHARMA INDUSTRY
NSF International's expert Martin Lush gives his insight into the political landscape and the future of the pharmaceutical industry. Watch this 30-minute webinar. many of the vertically integrated pharmaceutical companies that have long dominated the business began actively outsourcing many of t...

The Pharma Supply Chain Revolution
THE PHARMA SUPPLY CHAIN REVOLUTION
With the mounting external pressures and security of supply concerns, is Pharma ready to lead the supply chain revolution?Vendor Managed Inventory (VMI), coupled with Electronic data interchange (EDI), integrates your forecast into your vendor’s production plans. Throughout the product lifecyc...

New Business Models in Diagnostics and Drug Development
NEW BUSINESS MODELS IN DIAGNOSTICS AND DRUG DEVELOPMENT
Next-generation sequencing (NGS) has emerged as a key technology to deliver the next level of healthcare solutions. While the $1,000 genome was achieved in 2015, Frost & Sullivan predicts the $100 genome to be possible by 2024. The significant dip in cost of extracting genetic data has led to th...

NGS: New Business Models in Diagnostics and Drug Development
NGS: NEW BUSINESS MODELS IN DIAGNOSTICS AND DRUG DEVELOPMENT
Next-generation sequencing (NGS) has emerged as a key technology to deliver the next level of healthcare solutions. While the $1,000 genome was achieved in 2015, Frost & Sullivan predicts the $100 genome to be possible by 2024. The significant dip in cost of extracting genetic data has led to th...

The FDA
THE FDA'S MDM JOURNEY: A 360 VIEW OF THE GLOBAL DRUG SUPPLY CHAIN
The FDA Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER's primary mission is to promote and protect public health by ensuring availability...

Using HPE Mobile Center Platform at UCB BioPharma
USING HPE MOBILE CENTER PLATFORM AT UCB BIOPHARMA
Learn how UCB Biopharma is optimizing its Pharma Mobile Applications, over several countries, that are both user friendly and with top performing reliability.

Searching for drug safety and benefit-risk evaluations
SEARCHING FOR DRUG SAFETY AND BENEFIT-RISK EVALUATIONS
Scientific literature is one of the largest source of adverse event reports, making it an essential part of pharmacovigilance. Marketing authorization holders are expected to perform systematic literature searches using reference databases and local journals from countries where the medicinal produc...

Cause to cure: ESG engagement and research on food labelling and drug pricing
CAUSE TO CURE: ESG ENGAGEMENT AND RESEARCH ON FOOD LABELLING AND DRUG PRICING
Investors often have mixed views on the benefits of ESG engagement, especially within Big Industry sectors. As long-term stewards of client’s capital, our goal is to provide meaningful insights on our engagements with the aim of demonstrating how ESG research is good not only for investors in ...

Digital health: how can technology be used to engage hard-to-reach patients?
DIGITAL HEALTH: HOW CAN TECHNOLOGY BE USED TO ENGAGE HARD-TO-REACH PATIENTS?
Helping someone live with a condition as complex as MS can be fraught with challenges. MS professionals are asked to manage multiple physical and psychological symptoms while following complicated drug monitoring regimes, all in the face of shirking resources and growing caseloads.As the burden of m...

The evolution of pharma social media intelligence
THE EVOLUTION OF PHARMA SOCIAL MEDIA INTELLIGENCE
As shown in the consumer world, social media can be a very rich source of insights into customers and markets, and can provide early signals of new trends. Exactly the same is true for patient and health care provider insights, especially when used with other more traditional data sets. But understa...

Supporting Drug Safety with PharmaPendium and advanced FAERS searching
SUPPORTING DRUG SAFETY WITH PHARMAPENDIUM AND ADVANCED FAERS SEARCHING
Drug safety considerations impact the entire drug development lifecycle, from preclinical safety assessments to clinical trials to post-market. In this webinar, we will discuss how to leverage the comparative FDA and EMA regulatory information in PharmaPendium to inform translational and clinical de...

Leveling the Playing Field - Recruiting in Pharma and Med Device Companies
LEVELING THE PLAYING FIELD - RECRUITING IN PHARMA AND MED DEVICE COMPANIES
Recruiting top talent is a contentious process, especially in an industry as competitive as pharmaceutical and medical device. In the dog-eat-dog world, how do you set your company apart from rival organizations? Join us for this webinar on how the right business vehicle program can give you a hirin...

Drug Diversion in the Pharmacy: How Are You Preventing It?
DRUG DIVERSION IN THE PHARMACY: HOW ARE YOU PREVENTING IT?
Everyone knows drug diversion can be a major challenge in nursing units, but not everyone knows how to take preventive measures to reduce the risk of diversion in the central pharmacy. Join diversion expert Luke Overmire for guidance on how to prevent, detect, and react to diversion in your pharmacy...

Information Risk and Cyber Security - Pharmaceutical Industry in India
INFORMATION RISK AND CYBER SECURITY - PHARMACEUTICAL INDUSTRY IN INDIA
The Pharmaceutical sector is one of the top targets for data threats. According to a 2015 survey by Crown Records Management, a global consulting company, 2/3rd of pharma companies have suffered serious data breaches while 1/4th have been hacked! The primary reason for the threat is Intellectual Pro...

How can pharma support a more collaborative NHS through STPs and ICSs?
HOW CAN PHARMA SUPPORT A MORE COLLABORATIVE NHS THROUGH STPS AND ICSS?
Is your company prepared for the changes in the NHS, and is it aware of pharma’s potential to play a leading role in transforming services? Over the last few years, the government has been trying to reshape the NHS by making it more responsive to the health needs of regional populations. By di...

Enabling Next Generation Pharma Supply Chain: The Role of the Digital Platform
ENABLING NEXT GENERATION PHARMA SUPPLY CHAIN: THE ROLE OF THE DIGITAL PLATFORM
Damage, counterfeit, theft, delays: these are some of the most pressing challenges that pharma supply chain executives are facing. Consequences are not limited to disruptions and to higher costs for manually managing exceptions, identify irregularities, and tracing products: there's also direct ...

2016 Global pharma repTrak Webinar
2016 GLOBAL PHARMA REPTRAK WEBINAR
Watch the webinar to see the top pharmaceutical companies for 2016. Understand what the best pharmaceutical companies are doing to build reputation and support with the general public, including: Building a strong reputation across countries and dimensions.

Optimize and Transform Clinical Oncology Research
OPTIMIZE AND TRANSFORM CLINICAL ONCOLOGY RESEARCH
Oncology is leading the precision medicine revolution, as clinical researchers identify biomarkers to target patient subsets with more effective treatments. Yet there remains a scarcity of available patients for targeted therapy trials, and capturing, standardizing and analyzing app, sensor, imaging...

Real-Time Process Control for Healthy, High-Purity Water Systems
REAL-TIME PROCESS CONTROL FOR HEALTHY, HIGH-PURITY WATER SYSTEMS
Current water testing methods pose a risk to products because, oftentimes, the results are not available at the time the water is used. This webcast will discuss current regulations and the implementation of a new class of instrumentation, online water bioburden analyzers (OWBAs), on high-purity wat...

Sulfonyl Fluorides in Chemical Biology and Drug Discovery
SULFONYL FLUORIDES IN CHEMICAL BIOLOGY AND DRUG DISCOVERY
Sulfonyl fluorides are privileged protein-reactive functional groups due to their context-specific reactivity with a broad range of amino acid residues (tyrosine, serine, lysine, threonine, cysteine and histidine). As a result, they are ideally suited to a myriad of applications in chemical biology ...

Protecting your Pharma Intellectual Property during Out-Licensing
PROTECTING YOUR PHARMA INTELLECTUAL PROPERTY DURING OUT-LICENSING
How do you maintain confidentiality of your most valuable intellectual property when entering into the partnership relationships that are becoming increasingly common in that pharma industry? Pharma IQ has teamed up with leading experts Brainloop to give you a wide range of tips and advice on protec...

Rethinking Collaboration in Biologics Discovery
RETHINKING COLLABORATION IN BIOLOGICS DISCOVERY
Today’s biotherapeutics research labs need to be able to successfully work with big data (genomics), public data, and various classes of experimental data to effectively operate in the modern world of biologics R&D. This environment only becomes more complex as many organisations are explo...

NIR Spectroscopy for Assessing Blend Uniformity in the Pharmaceutical Industry
NIR SPECTROSCOPY FOR ASSESSING BLEND UNIFORMITY IN THE PHARMACEUTICAL INDUSTRY
Technological advancements in Near Infrared (NIR) instrumentation have resulted in a move from the laboratory to the manufacturing environment in a form factor suitable for process monitoring and control applications. Blend uniformity is considered as a Critical Quality Attribute (CQA) by regulatory...

UX for R&D Life Sciences
UX FOR R&D LIFE SCIENCES
Using scientific software can be a frustrating, error prone and time-consuming process resulting in less productive research. This webinar panel will advocate that User Experience (UX) design offers unlocked benefits to the R&D life science industry. UX design is an evidence-based design process...

Engineered Viruses as Precision Cancer Therapeutics
ENGINEERED VIRUSES AS PRECISION CANCER THERAPEUTICS
Oncolytic virotherapy, the use of viral vectors to treat cancer, holds huge promise. Viruses are natural DNA delivery vehicles evolved to target specific tissues and transform them. Oncolytic virotherapies harness these abilities for therapeutic rather than pathological results. By engineering the v...

Automating Biopharma Quality Control to Reduce Costs and Improve Compliance
AUTOMATING BIOPHARMA QUALITY CONTROL TO REDUCE COSTS AND IMPROVE COMPLIANCE
One report suggests that an average pharmaceutical manufacturing plant spends around €40M per year on quality control1. At the same time another report states that 79% of all 483 Warning Letters issued by the FDA in 2016 cited 21CFR part 11 data integrity issues. Whilst re-training is a common ...

Flow Cytometric Approach to Probiotic Cell Counting and Analysis
FLOW CYTOMETRIC APPROACH TO PROBIOTIC CELL COUNTING AND ANALYSIS
The complexity of the manufacturing process of probiotic supplements, along with increased demand and strict criteria for quality, potency and safety, in accordance to FDA regulations, necessitates that manufacturers continue to improve production processes that increase productivity and efficiency....

Steps to ensuring a successful audit effective risk assessment design
STEPS TO ENSURING A SUCCESSFUL AUDIT EFFECTIVE RISK ASSESSMENT DESIGN
When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination. The best way to locate sources of contamination is via risk assessment, best performed before a process has been implemented....

What to Make Next? Guiding Drug Design With In Silico Modeling
WHAT TO MAKE NEXT? GUIDING DRUG DESIGN WITH IN SILICO MODELING
What to make next? That’s a key question in every Pharma drug design cycle. With all of the information now available, how do we make better informed decisions of what small or large molecule to make and test next?
In this webinar, we discuss future direction of drug design software in ...

TOC for cleaning validation and faster turnaround of production equipment
TOC FOR CLEANING VALIDATION AND FASTER TURNAROUND OF PRODUCTION EQUIPMENT
This webinar demonstrated Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

Prescription Cost Roundup - Success & Failures Addressing Drug Inflation
PRESCRIPTION COST ROUNDUP - SUCCESS & FAILURES ADDRESSING DRUG INFLATION
Can Make Specialty Pharmacy Drugs More Affordable Why Healthcare Doesn't Deliver in a Click & Ship World Best Practices for Creating Health Plan Moments of Magic How Essilor Doubled Healthcare Plan Utilization in 12 Months Prescription Cost Roundup - Success & Failures Addressing Drug In...

QbD applications for lipid-based pharmaceutical products
QBD APPLICATIONS FOR LIPID-BASED PHARMACEUTICAL PRODUCTS
In this webinar, Capsugel experts discussed the application of Quality by Design (QbD) to lipid-based formulations (LBF). QbD applied through scientific approaches to the development and finalisation of LBF commercial processes can shorten project timelines while reducing risks and gaining valuable ...

Understanding ISO 21501-4: Particle Counter Calibration
UNDERSTANDING ISO 21501-4: PARTICLE COUNTER CALIBRATION
ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO 14644. What attendees learnt during this webinar: 
• How to be compliant with the most recent calibration requirements
• Sampling f...

Solutions to keep your thermal analysis work in line with FDA requirements
SOLUTIONS TO KEEP YOUR THERMAL ANALYSIS WORK IN LINE WITH FDA REQUIREMENTS
The FDA 21 CFR 11 regulations specify three types of controls. Procedural and administrative controls are the responsibility in contrast to technical controls that are the responsibility of the software supplier.
The CFR STARe software option allows the user to work with a compliant system un...

Use of MicroNIR to optimise fluid bed drying and to reduce waste at tablet compression
USE OF MICRONIR TO OPTIMISE FLUID BED DRYING AND TO REDUCE WASTE AT TABLET COMPRESSION
Pfizer has been studying the use of MicroNIR for several years and has been working to develop fit-for-purpose packages for specific pharmaceutical unit operations.
This webinar discussed two of these packages:
- A MicroNIR used to monitor fluid bed drying operation and included inside...

Application of HDX-MS for drug discovery and development
APPLICATION OF HDX-MS FOR DRUG DISCOVERY AND DEVELOPMENT
Amide hydrogen/deuterium exchange coupled with mass spectrometry (HDX-MS) has become increasingly popular technology to study protein dynamics, protein-ligand interactions, and protein-protein interactions. Particularly interesting applications of the technology include biosimilars, nuclear receptor...

TGA-MS or TGA-FTIR systems allow you to perform evolved gas analysis
TGA-MS OR TGA-FTIR SYSTEMS ALLOW YOU TO PERFORM EVOLVED GAS ANALYSIS
Thermogravimetric Analysis (TGA) provides quantitative information on the change in mass of a sample as a function of time or temperature. But TGA cannot identify or characterise the gaseous products evolved during a measurement. The combination of a TGA with a mass spectrometer (MS) or a Fourier tr...

How to Optimize Your Drug Label Using Biosimulation Methodology
HOW TO OPTIMIZE YOUR DRUG LABEL USING BIOSIMULATION METHODOLOGY
While biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key l...

The EU
THE EU'S NEW MEDICAL DEVICE AND IVD REGULATIONS
The new EU Medical Device and IVD Regulations, recently published in the Official Journal of the European Union on May 5, 2017, have set into force a series of compliance deadlines and processes that include three- and five-year transition periods.

Pharmacopoeias: Basics for Compendial Compliance
PHARMACOPOEIAS: BASICS FOR COMPENDIAL COMPLIANCE
This instructional webinar is designed for individuals with responsibility for ensuring compliance with requirements in the pharmacopeias and is broadly applicable to the global bio/pharmaceutical industry, including innovator, generic, biotechnology, consumer-care and related industries.

Critical Drug Substance Considerations for Formulation Success in Drug Product Development
CRITICAL DRUG SUBSTANCE CONSIDERATIONS FOR FORMULATION SUCCESS IN DRUG PRODUCT DEVELOPMENT
Join Alcami for a webinar discussing critical drug substance considerations for formulation success in drug product development. Understanding the solid state properties of a drug candidate molecule is of critical importance for successful dosage form development.

Drug-On-Demand: A Mini-Manufacturing Method Using Drop-On-Demand Technology
DRUG-ON-DEMAND: A MINI-MANUFACTURING METHOD USING DROP-ON-DEMAND TECHNOLOGY
In recent years, the FDA has encouraged pharmaceutical companies to place renewed emphasis on model-based process design and the development of more innovative, efficient manufacturing methods. “Mini-manufacturing” of medicine can alleviate the need to mass-manufacture all drugs and can ...

Advancing Base Metal Catalysis in Pharma
ADVANCING BASE METAL CATALYSIS IN PHARMA
In 60 minutes, this webinar will discuss the pros and cons of base metal catalysts and precious metal catalysts from a cost, toxicity and supply risk perspective. You’ll consider the application of copper, iron and nickel base metal catalysts to metal-catalyzed cross-coupling reactions. You&rs...

Harnessing Emerging Technologies to Obtain the Best Chemical Information from Pharmaceutical Products
HARNESSING EMERGING TECHNOLOGIES TO OBTAIN THE BEST CHEMICAL INFORMATION FROM PHARMACEUTICAL PRODUCTS
The extraneous material, such as micro-particles, found in the manufacturing stream of biopharmaceuticals must be identified and the root cause must be determined to take corrective actions. Biopharmaceuticals differ significantly from conventional pharmaceutics in manufacturing and delivery.

Making continuous processing a reality in the pharmaceutical industry
MAKING CONTINUOUS PROCESSING A REALITY IN THE PHARMACEUTICAL INDUSTRY
The principal benefits of continuous processing are considered to be reduced cost, increased speed, agility, and quality. Use of such technology for pharmaceutical products is in its relative infancy despite the existence of appropriate processing platforms. Notable perceived barriers to the use of ...

Overcome Hurdles to Effective Pharmaceutical Marketing
OVERCOME HURDLES TO EFFECTIVE PHARMACEUTICAL MARKETING
Regulations: What are the most often cited violations? Are pharma marketers getting better at compliance? Cautionary tales – beware of agencies with limited regulatory experience. Ethics: Why are ethics in marketing important? What ethical principles should pharmaceutical marketers obey, espec...

Pharmaceutical Serialisation – Opportunities and Aggregation in the Future
PHARMACEUTICAL SERIALISATION – OPPORTUNITIES AND AGGREGATION IN THE FUTURE
Serialisation is a means to track and trace products to help overcome counterfeit drugs. Serialisation legislation is already enforced in Brazil, South Korea, and China, due to come into effect in the US in 2017, and in all European countries by Feb 2019 for all prescription drugs.

Webinar about combination products: Bridging the gap between pharma and medical devices
WEBINAR ABOUT COMBINATION PRODUCTS: BRIDGING THE GAP BETWEEN PHARMA AND MEDICAL DEVICES
We will provide a new understanding of key topics that separate the regulatory and quality process for drugs and combination products/drug delivery devices.  We understand the process of drug development and certification varies greatly from the process for medical devices.

Medicaid Drug Rebate Program Digital Week Webinar
MEDICAID DRUG REBATE PROGRAM DIGITAL WEEK WEBINAR
In this session, we will cover:
  • State Reimbursement of 340B in Medicaid FFS
  • How states plan to identify 340B claims in Medicaid FFS
  • The impact of the new 340B FFS state policies on manufactures
  • ...

Immuno-oncology
IMMUNO-ONCOLOGY'S EVOLUTION: IMPLICATIONS FOR PHARMA MARKET RESEARCHE
Immuno-oncology therapies that harness the body’s own defenses to fight tumors are widely acknowledged as the new frontier in cancer treatment, but until recently only a few products had reached the market for a limited number of indications. Over the past 12 months several new products have b...

Evaluating Extractable & Leachable Profiles of 3D Printed Medical Devices Using High-Resolution Mass Spectrometry
EVALUATING EXTRACTABLE & LEACHABLE PROFILES OF 3D PRINTED MEDICAL DEVICES USING HIGH-RESOLUTION MASS SPECTROMETRY
The use of 3D printed medical devices is a growing field, due to product customizability, short lead times, and ability to create devices not possible with traditional manufacturing techniques. Despite this trend, there has been the little study of the chemical constituents of 3D printed medical dev...

Launching into Value: Pharma’s Quest to Align Drug Prices with Outcomes
LAUNCHING INTO VALUE: PHARMA’S QUEST TO ALIGN DRUG PRICES WITH OUTCOMES
With intense pressure on drug prices, the pharmaceutical industry is turning to value-based contracts – which link the price of a prescription drug to its clinical or economic performance – to ease the tension. But the use of these new drug pricing models with insurers remains limited, d...

The Pharmaceutical Marketer’s Forecast for 2017
THE PHARMACEUTICAL MARKETER’S FORECAST FOR 2017
As a pharma marketer, you need to connect with patients, healthcare providers, and caregivers. And, that requires building trust, direct dialogue, and developing relationships. Get the tools to do that even better at LiveWorld’s webinar, The Pharmaceutical Marketer's Forecast for 2017.

Precision Medicine: Opportunities and Challenges for Clinical Trials
PRECISION MEDICINE: OPPORTUNITIES AND CHALLENGES FOR CLINICAL TRIALS
The momentum and muscle behind “finding the right drug for the right patient at the right dose” has further escalated with former President Barack Obama’s announcement of a $215 million-dollar Precision Medicine Initiative. In this webinar, Dr. Frank Smith explores the advances in ...

Pharma and proactive, preventative healthcare: how to use the pharmacy channel
PHARMA AND PROACTIVE, PREVENTATIVE HEALTHCARE: HOW TO USE THE PHARMACY CHANNEL
Across Europe, a shift towards greater prevention, earlier diagnosis and treatment is needed in order to contain the growing cost of healthcare. But how can healthcare systems make this transition – and how do pharmaceutical companies play a role in this, while also growing their market.

Disruptive Change: Precision Medicine Driving the Future
DISRUPTIVE CHANGE: PRECISION MEDICINE DRIVING THE FUTURE
In the backdrop of pharmaceutical and biotech company’s relentless pursuit in developing the next revolutionary treatment to improve patient’s lives another innovation revolution is rising, ‘precision medicine’. This endeavor is an agglomeration of diverse gargantuan and smaller specialized inventiv...

Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
BEST PRACTICES FOR EXTRACTABLES AND LEACHABLES TESTING FOR PRIMARY DRUG PRODUCT PACKAGING
The potential for harmful chemicals to be extracted from packaging materials and pose a risk to patients has spurred regulatory authorities to establish guidelines for extractable and leachable testing for primary drug packaging materials. Drug license holders must establish programs that effectivel...

Pharmaceutical Case Studies Illustrating Data Analytics Strategies
PHARMACEUTICAL CASE STUDIES ILLUSTRATING DATA ANALYTICS STRATEGIES
Data Rich, Information Poor. Choosing the appropriate data management and visualization components are important. How many times have you wanted to investigate a key issue, or proactively design a new process, only to be stopped in your tracks because you don't have the data you need? Do you often d...

The investigation of pharmaceutical substances by thermal analysis
THE INVESTIGATION OF PHARMACEUTICAL SUBSTANCES BY THERMAL ANALYSIS
Thermal Analysis is often used to investigate pharmaceutical substances. Polymorphism, pseudo-polymorphism, phase diagrams, stability, and purity determination can all be measured by thermal analysis. The four main techniques of thermal analysis, DSC, TGA, TMA, and DMA are ideal for characterising s...

4 KEY POINTS FOR A FUTURE-PROOF DRUG SERIALIZATION SOLUTION
4 KEY POINTS FOR A FUTURE-PROOF DRUG SERIALIZATION SOLUTION
Serialization is a complex problem, not only in the pharmaceutical industry. The window to identify and mitigate risks is shrinking as mandated deadlines draw near in the USA (DSCSA) or in Europe (EU FMD).

FDA Perspectives on Implementation of the Drug Supply Chain Security Act
FDA PERSPECTIVES ON IMPLEMENTATION OF THE DRUG SUPPLY CHAIN SECURITY ACT
This virtual event is geared to provide pharmaceutical distributors, manufacturers, retailers and their service providers an opportunity to hear an overview of the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act), FDA’s implementation plan for the law and an update on F...

Securing and Illuminating the Pharmaceutical Supply Chain
SECURING AND ILLUMINATING THE PHARMACEUTICAL SUPPLY CHAIN
Supply chain management has always been a key challenge for pharmaceutical companies and their trading partners. Instances of drug counterfeiting, cargo thefts, in-transit damages due to environmental conditions etc. highlight the need for security and track and trace in pharma logistics.

Instrumental analysis in the regulated environment - how can you qualify your results from pharmacopeial monograph methods?
INSTRUMENTAL ANALYSIS IN THE REGULATED ENVIRONMENT - HOW CAN YOU QUALIFY YOUR RESULTS FROM PHARMACOPEIAL MONOGRAPH METHODS?
The focus of this webinar is regulated instrumental analysis; specifically, chromatographic testing of small molecules and excipients, heavy-metal content, water content; and changes in regulatory environment (USP/EP/ChP). We discuss how you can make sure to qualify your results and comply with the ...

Managing and Securing Legacy Medical Devices
MANAGING AND SECURING LEGACY MEDICAL DEVICES
Healthcare organizations are waking up to the reality that legacy medical devices are vulnerable entry points into their IT networks and an integrated approach to medical device management is necessary now, more than ever. We will discuss the Integration of device management and security across thei...

Realizing the Promise of Precision Medicine
REALIZING THE PROMISE OF PRECISION MEDICINE
The obstacles to personalized medicine include the high cost of precision cancer drugs, the challenge of getting patients fully engaged in their own care, a lack of mature, universal interoperability, and questions about the effectiveness of precision medicine interventions.

Pharma’s digital landscape: the evolution of multichannel strategy
PHARMA’S DIGITAL LANDSCAPE: THE EVOLUTION OF MULTICHANNEL STRATEGY
Pharmaceutical marketers are increasingly native multichannel practitioners, but building an effective and efficient campaign is challenging. This is also because the digital landscape, and the number of options available is still rapidly evolving. What are the best ways to choose the right channels...

Strategic Approach for Manufacturing Solid Dosage Forms
STRATEGIC APPROACH FOR MANUFACTURING SOLID DOSAGE FORMS
When driving compounds from development to clinic and commercial, it is important to provide a customized plan to achieve clinical and commercial success. A key aspect to this is selecting which process you will use to manufacture your product. Roller Compaction has become an important manufacturing...

Case Studies Utilizing iPSC-Derived Cardiomyocytes in Drug Discovery
CASE STUDIES UTILIZING IPSC-DERIVED CARDIOMYOCYTES IN DRUG DISCOVERY
The most prominent issue facing pharmaceutical R&D is the continuing late-stage failures of drug candidates. Though novel technologies and screening techniques have continued to provide researchers with more information and predictive tools, getting drugs into the clinic is less efficient than it ha...

5 Key Points for a Future Proof Drug Serialization Solution
5 KEY POINTS FOR A FUTURE PROOF DRUG SERIALIZATION SOLUTION
Understand the Complexity of Drug Serialization, including fast approaching deadlines and regulatory requirements. Discover the many complex scenarios involved in serialization including codification standards, market regulations and pharmaceutical company requirements.

Pharma documentation, Anton Paar in the Qualification Process
PHARMA DOCUMENTATION, ANTON PAAR IN THE QUALIFICATION PROCESS
A detailed explanation on how Anton Paar Pharma Qualification Packages(PQP) can help you in the pharmaceutical industry to save time, money and be ready for an audit. The webinar will focus on:Anton Paar PQP features and benefits, Engineers, lab specialists, chemists, researchers, students and all o...

Approval and access: Overcoming the final hurdle of drug development
APPROVAL AND ACCESS: OVERCOMING THE FINAL HURDLE OF DRUG DEVELOPMENT
2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region. There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic p...

PHARMA TRENDS IN EMERGING MARKETS
PHARMA TRENDS IN EMERGING MARKETS
Request a recording of this webinar from May 25, 2017 to learn more about the promise of emerging markets by looking at the activity and trends in the pharmaceutical industry in Brazil, Russia, India, China and South Korea (BRICS). Provides trends M&A and Licensing in emerging markets for exploring ...

Webinar: Augmented Reality in Medicine, Health and Wellness
WEBINAR: AUGMENTED REALITY IN MEDICINE, HEALTH AND WELLNESS
The fields of medicine, healthcare and wellness have long embraced the use of new technology to improve patient outcomes and quality of life. The introduction of Augmented Reality-assisted systems is going hand in hand with the increase in real time data we are able to capture and analyze about the ...

Using Model Reduction to Bridge the Quantitative Systems Pharmacology-Pharmacometrics Divide
USING MODEL REDUCTION TO BRIDGE THE QUANTITATIVE SYSTEMS PHARMACOLOGY-PHARMACOMETRICS DIVIDE
One of the biggest challenges and, hence, the biggest opportunity for quantitative systems pharmacology (QSP) is drug attrition in Phase 2 clinical trials. Investigational medicines are usually tested for the first time in patients in Phase 2 clinical trials. This is the point when many drug program...

Use of TOC Analysis in the Pharmaceutical Industry
USE OF TOC ANALYSIS IN THE PHARMACEUTICAL INDUSTRY
This webinar will walk through the process and benefits implementing the use of Total Organic Carbon (TOC) in Pharmaceutical. We will talk through the use of TOC analysis in Pharmaceutical water, for performing Cleaning Validation, Replacing HPLC with TOC for CV, for checking the extractable and lea...

On-demand Program: FDA Hot Topics: 2015 Update on Medical Device Guidances
ON-DEMAND PROGRAM: FDA HOT TOPICS: 2015 UPDATE ON MEDICAL DEVICE GUIDANCES
So much has transpired in the last year with the Food and Drug Administration (FDA) that it is hard to keep up with all the new initiatives represented in a myriad of new agency guidance documents. Join RAPS, Wednesday 9 September, with industry-leading speakers in a half-day virtual program to disc...

SIFT-MS: A New Tool for Impurity Profiling in Pharmaceutical Products
SIFT-MS: A NEW TOOL FOR IMPURITY PROFILING IN PHARMACEUTICAL PRODUCTS
SIFT-MS is a new tool for real-time, selective and economical trace gas and headspace analysis. SIFT-MS uses soft chemical ionization to quantify volatile compounds, including chromatographically challenging ones such as formaldehyde, formic acid, and ammonia.

Drug Documents and Device Documents: Definitions and IRB Review
DRUG DOCUMENTS AND DEVICE DOCUMENTS: DEFINITIONS AND IRB REVIEW
Why Do Drug or Device Documents Need to Be Submitted to the IRB? The IRB must conduct a risk/benefit analysis during review-Applies to device studies as well as studies utilizing a drug-IRB needs to determine that the benefits of study participation outweigh the risks.

Implementing Risk Strategies for the Pharmaceutical Supply Chain
IMPLEMENTING RISK STRATEGIES FOR THE PHARMACEUTICAL SUPPLY CHAIN
Business dynamics today are more complex than ever before. Globalization, product competition, and expanding supplier networks drive companies into many directions. Regulatory requirements force organizations to employ more traceability on product throughout the supply chain. All this, and companies...

Going Paperless in Pharmaceutical Manufacturing
GOING PAPERLESS IN PHARMACEUTICAL MANUFACTURING
The Life Sciences Industry adheres to a strict manufacturing process. In this webinar, we'll provide insights on: Eliminating manual processes, while remaining FDA 21 CFR Part 11 compliant, Reducing reporting discrepancies due to human errors and securing data integrity.

The Changing Market for Drugs to Treat Orphan Diseases
THE CHANGING MARKET FOR DRUGS TO TREAT ORPHAN DISEASES
The environment for payer coverage and reimbursement of new treatments for orphan diseases will become increasingly restrictive in the years to come. In case you missed the QuintilesIMS presentation at the 2017 Market Access Conference, this webinar will offer strategies for effective pricing and br...

Pragmatic Solutions for Immuno-Oncology Clinical Trial Programs: Covance Webinar
PRAGMATIC SOLUTIONS FOR IMMUNO-ONCOLOGY CLINICAL TRIAL PROGRAMS: COVANCE WEBINAR
Covance will teach you how to utilize historical data-driven methodology to identify investigators who are consistently excellent performers to ensure trial success.

What Do the New DEA Pharmaceutical Regulations Mean For Your Organization?
WHAT DO THE NEW DEA PHARMACEUTICAL REGULATIONS MEAN FOR YOUR ORGANIZATION?
This webinar will tell you what you need to know regarding most recent pharmaceutical regulations from the DEA. You will learn: How pharmaceutical disposal and drop-off rules could impact your organization, what you should do to stay compliant.

Exploring ADC Pharmacokinetics using QSP Modeling Strategies
EXPLORING ADC PHARMACOKINETICS USING QSP MODELING STRATEGIES
The Pharmacokinetics (PK) of ADC therapeutics typically show a discrepancy between the PK of total antibody and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation, however recent evidence suggests that the underlying mechanisms ...

Counterfeiting in pharma and medical devices
COUNTERFEITING IN PHARMA AND MEDICAL DEVICES
As pharma companies have improved patients’ access to safe medicines, the value of pharma brands has grown. It is attracting not just investors, but also counterfeiters. The WHO estimates up to 8% of medical devices on the market are fakes, as are up to 30% of medicines. The rise of new technologies...

Predicting Drug Exposure During Pregnancy Using PBPK Models
PREDICTING DRUG EXPOSURE DURING PREGNANCY USING PBPK MODELS
Pregnancy is associated with numerous physiologic changes that can influence absorption, distribution, metabolism and excretion of medications. Moreover, the magnitude of these changes differs over the course of the pregnancy. For most medications, limited information is available about changes in d...

Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs
EMERGING ISSUES FOR PHARMA R&D: A PRACTICAL APPROACH FOR PEDIATRIC DRUG PROGRAMS
Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Maturation of metabolic capacity and renal function can impact drug clearance. In addition, changes in body composition can alter volumes of dist...

EFFICIENT DRUG SERIALIZATION ROLL-OUT AND OEE MANAGEMENT
EFFICIENT DRUG SERIALIZATION ROLL-OUT AND OEE MANAGEMENT
Multiple, fast approaching and moving deadlines for drug serialization implementation create an extraordinary level of complexity to cope with for pharmaceutical companies, drug manufacturers and packagers. The window to identify, mitigate risks and gain clarity on uncertainties is shrinking as mand...

Pharmaceutical Serialization – Best Practices for Global Commercial Supply in an Evolving Market
PHARMACEUTICAL SERIALIZATION – BEST PRACTICES FOR GLOBAL COMMERCIAL SUPPLY IN AN EVOLVING MARKET
PCI's global head of serialization, Ian Parsonage, will share his experiences in developing PCI's serialization technology platform, along with developing and executing PCI's strategy for supplying commercial serialized products to domestic and emerging markets across the globe. Pharmaceutical seria...

Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned
OUTSOURCING PHARMACOVIGILANCE: PROS AND CONS AND LESSONS LEARNED
As the demand for new therapies increases, so does the need to comply with regulatory requirements across the pharmaceutical industry, which is on the constant lookout for newer, more efficient ways to tackle the ever-increasing load of adverse event data. Sometimes the need is driven by a lack of a...

What does
WHAT DOES 'THE CLOUD' MEAN FOR PHARMA?
It is likely that you interact with ‘the cloud’ on various devices, multiple times throughout the day. However, for pharma we have only just scratched the surface regarding what the cloud can offer in terms of security, connectivity and efficacy. ‘Business analytics’ and ‘cloud’ are often misunderst...

Patient-Centric Drug Delivery Strategies for Oral Paediatric Products
PATIENT-CENTRIC DRUG DELIVERY STRATEGIES FOR ORAL PAEDIATRIC PRODUCTS
The webinar will give an overview about general drug delivery requirements for paediatric drug products and current discussions concerning the EU and US regulations. In-depth Case Studies featuring Patient-centric Paediatric formulations, will also be presented.

Micro-Flow Imaging as a Tool for Biopharmaceutical Particle Analysis
MICRO-FLOW IMAGING AS A TOOL FOR BIOPHARMACEUTICAL PARTICLE ANALYSIS
The size of poly(lactic-co-glycolic) acid (PLGA) microparticles is of critical importance for polymer degradation and drug release rates. Current methods for the characterization of PLGA microparticle size provide only limited or no quantitative information or may overestimate size due to the presen...

Pharmaceuticals Market Briefing
PHARMACEUTICALS MARKET BRIEFING
The Asia Pacific is the third largest pharmaceutical market in the world after North America and Europe, with generics being the major driver for the pharmaceutical industry in this region, aided by factors such as the aging population and impending expiry of patented drugs. It is a necessity for ph...

Discover better designs, faster, and solve drug delivery challenges for the pharmaceutical and medical device industries
DISCOVER BETTER DESIGNS, FASTER, AND SOLVE DRUG DELIVERY CHALLENGES FOR THE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES
In order to design effective drug delivery devices, one has to master the physics of liquids, solids, gases and any of their combinations. From drug formulation, drug transport all the way to drug delivery, from powders, solids to fluids and vapors, computational fluid dynamics (CFD) can be a powerf...

Transparency Matters: Challenges Facing the Global Pharmaceutical Industry and a Fresh Look at Transparency and Disruptive Innovation
TRANSPARENCY MATTERS: CHALLENGES FACING THE GLOBAL PHARMACEUTICAL INDUSTRY AND A FRESH LOOK AT TRANSPARENCY AND DISRUPTIVE INNOVATION
In this Atheneum sponsored webinar, Mr. Les C. Meyer discusses the challenges facing the global pharmaceutical industry and gives a fresh look at transparency and disruptive innovation within the Health Care industry.

Pharmaceutical Product & Process Understanding
PHARMACEUTICAL PRODUCT & PROCESS UNDERSTANDING
What is helping and/or preventing today's companies from putting their process and quality data to work? BIOVIA and Pharmaceutical Manufacturing partnered to conduct a survey to learn more about current product and process understanding approaches among life sciences manufacturers, and to identify o...

NIR Spectroscopy for Assessing Blend Uniformity in the Pharmaceutical Industry
NIR SPECTROSCOPY FOR ASSESSING BLEND UNIFORMITY IN THE PHARMACEUTICAL INDUSTRY
Technological advancements in Near Infrared (NIR) instrumentation have resulted in a move from the laboratory to the manufacturing environment in a form factor suitable for process monitoring and control applications. Blend uniformity is considered as a Critical Quality Attribute (CQA) by regulatory...

Quality by design in pharmaceutical manufacturing
QUALITY BY DESIGN IN PHARMACEUTICAL MANUFACTURING
Pharmaceutical Manufacturers increasingly use the Quality by Design (QbD) concept to build quality assurance into their processes and ensure consistent accuracy of results. Weighing can significantly influence product quality and is an essential part of QbD processes in pharmaceutical manufacturing....

QbD applications for lipid-based pharmaceutical products
QBD APPLICATIONS FOR LIPID-BASED PHARMACEUTICAL PRODUCTS
In this webinar, Capsugel experts discussed the application of Quality by Design (QbD) to lipid-based formulations (LBF). QbD applied through scientific approaches to the development and finalisation of LBF commercial processes can shorten project timelines while reducing risks and gaining valuable ...

On-Demand Webinar: Regulatory Compliance – Weighing in Pharma Manufacturing
ON-DEMAND WEBINAR: REGULATORY COMPLIANCE – WEIGHING IN PHARMA MANUFACTURING
Weighing applications in pharmaceutical production can strongly influence the quality and integrity of the final product. However, regulations on how to select the right weighing equipment or determine a correct testing strategy often remain vague. This leaves pharma manufacturers with a lot of ques...

Raman detection of Counterfeit Pharmaceuticals
RAMAN DETECTION OF COUNTERFEIT PHARMACEUTICALS
The use of Raman spectroscopy is widespread and well-established within Pharmaceutical analysis. In particular, hand-held devices are widely used in the detection of counterfeit drugs and for assessing stability of products, etc. But how robust is their analysis when the spectra of real and counterf...

Production & Sterilization of Biopharmaceutical Nanoemulsions using Filtration: Microfluidics and Pall Life Sciences Collaborate to Develop a Filtration- based Alternative to Terminal Sterilization for a Squalane Emulsion
PRODUCTION & STERILIZATION OF BIOPHARMACEUTICAL NANOEMULSIONS USING FILTRATION: MICROFLUIDICS AND PALL LIFE SCIENCES COLLABORATE TO DEVELOP A FILTRATION- BASED ALTERNATIVE TO TERMINAL STERILIZATION FOR A SQUALANE EMULSION
Nanoemulsions have many advantages to the pharmaceutical industry as drug delivery systems. These advantages include increased drug loading, enhanced bioavailability, protection from degradation, and controlled drug release. Additionally, the ability of nanoemulsions to enhance immune response makes...

THE PHARMACEUTICAL & HEALTHCARE MOBILITY OPEN HOUSE
THE PHARMACEUTICAL & HEALTHCARE MOBILITY OPEN HOUSE
In March, Pharma IQ launched the The Pharmaceutical & Healthcare Mobility Open House for 250+ industry decision makers to discover the true potential of mobility in Pharma and gain an understanding through case studies of how they can be best integrated into their workflows. The event provided a pla...

New Developments in Formulation Strategies for Poorly Water Soluble Drugs
NEW DEVELOPMENTS IN FORMULATION STRATEGIES FOR POORLY WATER SOLUBLE DRUGS
In this session, Professors Müllertz and Rades focused on new developments and possibilities in amorphous and lipid based drug delivery systems. Key takeaways: To develop enabling formulations you need to know the physicochemical basis to select the right drug for the right approach. Co-amorphous ap...

Non-Invasive Delivery of Macromolecular Biopharmaceuticals
NON-INVASIVE DELIVERY OF MACROMOLECULAR BIOPHARMACEUTICALS
A recorded webinar with Prof. Dr. Claus-Michael Lehr, Head, Dept. of Drug Delivery, Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS).- Oral, transdermal and pulmonary administration as the most attractive ones for non-invasive (needle free) delivery- Innovative approaches for designin...

Pediatric Clinical Drug Development
PEDIATRIC CLINICAL DRUG DEVELOPMENT
Pediatric clinical drug development has evolved rapidly in pharmaceutical companies over the last few years because of the encouragement of regulatory agencies in the United States (US) and Europe. Due to recent governmental initiatives such as the Pediatric Research Equity Act (PREA) in the US and ...

PHASE I cGMP DRUG MANUFACTURING AT THE CRU:3 KEY BENEFITS
PHASE I CGMP DRUG MANUFACTURING AT THE CRU:3 KEY BENEFITS
Drug manufacturing can make up to 40 percent of the total cost to develop a new chemical entity and can be an inflexible, time consuming and frustrating experience during your first-in-human clinical trial. But it doesn’t have to when you use a cGMP pharmacy at your clinical research unit (CRU) for ...

How to Optimize Biologic Drug Development with the Power of Scientific Informatics
HOW TO OPTIMIZE BIOLOGIC DRUG DEVELOPMENT WITH THE POWER OF SCIENTIFIC INFORMATICS
Many organizations in the pharmaceutical and biopharmaceutical industries have increased their efforts in biotherapeutic drug development to remain competitive by shifting their activities away from small molecule toward biologics drug development. The complex structure of Biologics, the nature of t...

Patent and Regulatory Issues for Pharmaceuticals
PATENT AND REGULATORY ISSUES FOR PHARMACEUTICALS
Dr. Anthony Sabatelli, head of Dilworth IP’s Pharmaceutical and Biotech Patent Practice, will be hosting the second of this year’s Dilworth IP Webinar Seminars on Wednesday March 2nd at 1:00 PM (EST). This session, entitled At the Intersection of Patent and Regulatory Law – Navigating the Challenges...

Discover the Latest Innovation in Pharmaceutical Primary Packaging
DISCOVER THE LATEST INNOVATION IN PHARMACEUTICAL PRIMARY PACKAGING
By 2020 biologics are expected to be 27% of the overall drug market versus 22% registered in 2013: this progressive growth of biologics, including biosimilars, are driving the need for new container platforms suitable for more concentrated drug formulations, featuring higher viscosity, complex and s...

Pharmaceutical Life Cycle Management: Updates on Navigating the IP, FDA and Antitrust Terrain
PHARMACEUTICAL LIFE CYCLE MANAGEMENT: UPDATES ON NAVIGATING THE IP, FDA AND ANTITRUST TERRAIN
There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop. Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of admi...

Customer engagement design in pharma
CUSTOMER ENGAGEMENT DESIGN IN PHARMA
In recent years pharma has slowly been realising the importance of customer experience and the fact that the commercial model that served it so well for the past 30 years might not be the right one for the future. But continued ‘evolution’ is no longer acceptable - a more revolutionary approach to c...

Critical Drug Substance Considerations for Formulation Success in Drug Product Development
CRITICAL DRUG SUBSTANCE CONSIDERATIONS FOR FORMULATION SUCCESS IN DRUG PRODUCT DEVELOPMENT
Join Alcami for a webinar discussing critical drug substance considerations for formulation success in drug product development. Understanding the solid-state properties of a drug candidate molecule is of critical importance for successful dosage form development. It takes close collaboration and co...

Marijuana Regulation in the Food and Drug Realm
MARIJUANA REGULATION IN THE FOOD AND DRUG REALM
Does the current state of marijuana regulation leave you confused? Attend this webinar to learn about the current state of marijuana regulation, and the legal quagmire between state legalization and federal enforcement. Speakers will address questions surrounding state marijuana regulation, includin...

New Elemental Impurities Tests for Pharmaceutical Products to Start in Less Than One Year. Are You ready?
NEW ELEMENTAL IMPURITIES TESTS FOR PHARMACEUTICAL PRODUCTS TO START IN LESS THAN ONE YEAR. ARE YOU READY?
The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which time manufacturers of pharmaceutical drug products must comply with USP and ICH Q3D. Recent harmonization between U...

Tackling Prescription Drug Prices: A Closer Look at State Policy Successes
TACKLING PRESCRIPTION DRUG PRICES: A CLOSER LOOK AT STATE POLICY SUCCESSES
The high cost of prescription drugs has commanded national attention, yet there have not been any successful national solutions. At the state level, there were over 80 Rx price-related bills introduced in 2017, but very few have crossed the finish line. This webinar, open only to state officials, wi...

How to build a data-driven pharmaceutical molecule discovery pipeline
HOW TO BUILD A DATA-DRIVEN PHARMACEUTICAL MOLECULE DISCOVERY PIPELINE
While innovation intelligence provides a wealth of data regarding future drug possibilities and their attachment to therapeutic areas, this information can be difficult to extract and integrate into workflows and processes. As such, it is hard for organizations to formulate a targeted strategy based...

Avoiding Pharmaceutical and Biopharmaceutical Data Integrity Problems
AVOIDING PHARMACEUTICAL AND BIOPHARMACEUTICAL DATA INTEGRITY PROBLEMS
This timely online training course will benefit professionals in the following FDA-regulated industries: Pharmaceuticals, Biopharmaceuticals, Vaccines, Cellular and Tissue Therapies and other Biologics, PET Drugs. This online training course will be of benefit to all persons whose span of responsibi...

Webinar: PS 9000:2016 Pharmaceutical Packaging Materials for Medicinal Products Update Standard
WEBINAR: PS 9000:2016 PHARMACEUTICAL PACKAGING MATERIALS FOR MEDICINAL PRODUCTS UPDATE STANDARD
IPAC-RS has collaborated with the Pharmaceutical Quality Group (PQG), the pharmaceutical industry and suppliers to develop the next generation of the well-established PS 9000 series of standards. IPAC-RS will host a free public webinar introduce this updated PS 9000 version of the standard. The stan...

The successful development and manufacturing of highly potent molecules
THE SUCCESSFUL DEVELOPMENT AND MANUFACTURING OF HIGHLY POTENT MOLECULES
Hosted by European Pharmaceutical Manufacturer magazine, the webinar has enabled professionals working in the field of highly potent molecules to understand the complexities of safe processing and key considerations when it comes to choosing an outsourcing partner. The presentation was delivered by ...

Emerging Biopharma and Rare Disease: The Top 5 Patient Engagement Solutions
EMERGING BIOPHARMA AND RARE DISEASE: THE TOP 5 PATIENT ENGAGEMENT SOLUTIONS
As if patient identification and engagement weren't challenging enough, add in a rare disease study, and it can feel like a daunting process. Patient populations are small and widely dispersed around the globe, and finding the proper sites to support these patients is difficult. As an emerging bioph...

Expedite Early Drug Development With Unique Pre-Formulation Techniques
EXPEDITE EARLY DRUG DEVELOPMENT WITH UNIQUE PRE-FORMULATION TECHNIQUES
The goal of pre-formulation is to establish the physical, chemical, and mechanical properties of a drug substance that provides a roadmap and a guide for how to formulate the molecule into a fit-for-purpose formulation. Get an in-depth review of pre-formulation techniques and learn how these techniq...

AbbVie Dermatology QSP Platform: Build Strategy and Applications in Psoriasis Drug Discovery and Clinical Development
ABBVIE DERMATOLOGY QSP PLATFORM: BUILD STRATEGY AND APPLICATIONS IN PSORIASIS DRUG DISCOVERY AND CLINICAL DEVELOPMENT
The presented QSP platform captures the dynamic interaction of the major pathways involved in Ps.The platform serves as a template for the dynamic physiological interactions between the skin, adaptive and innate immune systems components, immune cells life cycle regulation, in health and disease (no...

Bringing Quantitative and Systems Pharmacology to Drug Discovery: Implementation, Impact, and Challenges
BRINGING QUANTITATIVE AND SYSTEMS PHARMACOLOGY TO DRUG DISCOVERY: IMPLEMENTATION, IMPACT, AND CHALLENGES
Model-informed drug discovery uses quantitative and translational pharmacology to build and continuously improve the quantitative understanding of the relation between drug exposure, target engagement, efficacy, and safety in drug discovery. This webinar will discuss how quantitative and translation...

Leveraging Medical Insights for Better Healthcare Engagement
LEVERAGING MEDICAL INSIGHTS FOR BETTER HEALTHCARE ENGAGEMENT
It can be difficult for medical affairs teams to uncover actionable scientific insights from the volume of information coming in from the field—better yet, utilize those insights to inform strategic decision making.

Quantification of Variability and Uncertainty in Multi-Level Systems Pharmacology Models
QUANTIFICATION OF VARIABILITY AND UNCERTAINTY IN MULTI-LEVEL SYSTEMS PHARMACOLOGY MODELS
Abstract: Computational modelling in Systems Medicine and Systems Pharmacology addresses biological processes at different levels and scales. The quantification of model parameters from experimental data is a complicated task. It will be addressed how variance in data propagates into parameter estim...

Pharmacometricians and Statisticians in Drug Development: Can’t We All Just Get Along?
PHARMACOMETRICIANS AND STATISTICIANS IN DRUG DEVELOPMENT: CAN’T WE ALL JUST GET ALONG?
Using some light-hearted ‘stereotypes’ and informal examples, we will explore some fundamental differences between biostatisticians and pharmacometricians in drug development roles. These include visibility and familiarity to clinical teams, history in the pharmaceutical industry, types of models, ...

Experts Talk: Using Pharmaceutical ALM for GAMP 5 Compliance
EXPERTS TALK: USING PHARMACEUTICAL ALM FOR GAMP 5 COMPLIANCE
Drawing on the experience of our guest speaker Kálmán Keresztesi (Controsys Control Engineering Ltd.), the focus of this webinar is risk management and compliance in the pharma industry. Pharmaceutical companies face challenges when setting up distributed control systems or automated production syst...

Thermal Sintering for Controlled Drug Release of Hydrophilic Drugs
THERMAL SINTERING FOR CONTROLLED DRUG RELEASE OF HYDROPHILIC DRUGS
Proper drug release of high-dose hydrophilic drugs is a challenge for formulators since both the initial drug burst release, as well as the consequent sustained release, need to be controlled.Excipients can provide an answer to drug release challenges when their hydrophobic nature is coupled with th...

Exploring Pharmaceutical Manufacturer and Specialty Pharmacy Relationships: What You Can and Cannot Do
EXPLORING PHARMACEUTICAL MANUFACTURER AND SPECIALTY PHARMACY RELATIONSHIPS: WHAT YOU CAN AND CANNOT DO
In an industry where supply chains are closely monitored, patient data is king, and complex medications require high-touch services by distribution partners, biologics and pharmaceutical manufacturers have turned to specialty pharmacies to assist. However, these arrangements are closely scrutinized ...

How Can You De-Risk Your CNS Drug Development Process
HOW CAN YOU DE-RISK YOUR CNS DRUG DEVELOPMENT PROCESS
The discovery and development of CNS drugs is an extremely challenging process requiring large resources, long timelines and high associated costs. The high risk of failure leads a considerable reluctance to commit appropriate resources to sustain the development of novel therapeutic mechanisms.

Drug Repurposing Explained
DRUG REPURPOSING EXPLAINED' WEBINAR
Ahead of Findacure’s drug repurposing conference, we have teamed up with Healx to offer our first webinar: 'Drug Repurposing Explained'. With conventional drug discovery being a lengthy and costly process, there is now much discussion about drug repurposing, and how it can bring more effective and c...

Advantages of Handheld Raman in the Pharmaceutical Industry
ADVANTAGES OF HANDHELD RAMAN IN THE PHARMACEUTICAL INDUSTRY
In this webinar, we’ll discuss various aspects of Raman, including the reasons the industry is interested in the technology, data integrity, method development, how samples are scanned, and challenges that have been conquered. We’ll also discuss the importance of validation of instrumentation, how P...

Demystifying the New EPA Hazardous Pharmaceutical Waste Rule
DEMYSTIFYING THE NEW EPA HAZARDOUS PHARMACEUTICAL WASTE RULE
This presentation provides an overview of the major issues affecting pharmaceutical waste management, insight in to the new rule proposed by the EPA regarding hazardous pharmaceutical waste, and what it means to healthcare facilities and reverse distributors.

Drug Development Beyond the FDA/EMA
DRUG DEVELOPMENT BEYOND THE FDA/EMA
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of lo...

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance
DRUG SAFETY AND PHARMACOVIGILANCE: EFFECTIVE DRUG SAFETY REPORTING AND SURVEILLANCE
This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in ...

Powering pharma’s commercial teams with market access insights
POWERING PHARMA’S COMMERCIAL TEAMS WITH MARKET ACCESS INSIGHTS
Market access is influencing drug development and commercial launch strategy more than ever before, with 85% of prescription drugs in the United States reimbursed through managed care plans.

Drug Interactions with Hormonal Contraception
DRUG INTERACTIONS WITH HORMONAL CONTRACEPTION
This guidance provides evidence-based recommendations and good practice points for health professionals with regards to interactions between hormonal contraception and other drugs. It is intended for any health care professional or health service providing contraception or conception advice in the U...

Food & Health webinar series: Pharmaceutical testing
FOOD & HEALTH WEBINAR SERIES: PHARMACEUTICAL TESTING
Pharmaceutical products are typically drugs and other chemical preparations used to diagnose, cure, treat or prevent disease. These products also comes in multiple forms such as tablets, capsules, soft gels and others. As it plays a critical role in treatment of diseases or maintenance of good healt...

Advanced Program in Pharmaceutical Quality Management
ADVANCED PROGRAM IN PHARMACEUTICAL QUALITY MANAGEMENT
We live in a world of constant economic and political change. Pair this industry unpredictability with regulatory disruptions that have had an unprecedented impact on businesses and the image of our industry, and the need for a formal education of international standards focusing on pharmaceutical q...

Recent Survey Reveals Compliance the Greatest Challenge for Drug Safety Teams
RECENT SURVEY REVEALS COMPLIANCE THE GREATEST CHALLENGE FOR DRUG SAFETY TEAMS
A common trend amongst drug safety departments in life science companies is that they’re being asked to do more with less, without compromising quality or compliance. As case volumes and complexities increase, many safety departments simply cannot survive if they continue with their current ri...

Fueling Innovation: Understanding the Role of Ontologies in Biopharmaceutical Research
FUELING INNOVATION: UNDERSTANDING THE ROLE OF ONTOLOGIES IN BIOPHARMACEUTICAL RESEARCH
Fundamentally, ontologies are created to identify and define concepts and their relationships within a subject domain. In the world of biopharmaceutical research, where progress depends heavily on extracting relevant information from enormous repositories of both internal and external data, ontologi...

A Quest for Convenience: Drug Take-Back at Retail Pharmacies - Webinar Recording
A QUEST FOR CONVENIENCE: DRUG TAKE-BACK AT RETAIL PHARMACIES - WEBINAR RECORDING
When the DEA published its final rule last September, they expanded the number and types of entities that may be permitted to collect unwanted medications, making way for more numerous and convenient collection options for consumers. The rule allows manufacturers, distributors, reverse distributors,...

New DOT Special Permit for Collected Pharmaceuticals - Webinar Recording
NEW DOT SPECIAL PERMIT FOR COLLECTED PHARMACEUTICALS - WEBINAR RECORDING
Recently, the Pipeline and Hazardous Materials Safety Administration (PHMSA), within the U.S. Department of Transportation, issued two special permits for the shipment of liners containing collected materials from drug take-back programs. When the U.S. Drug Enforcement Administration (DEA) published...

Best Practices for Running Pharmacy-Based Drug Take-Back - Webinar Recording
BEST PRACTICES FOR RUNNING PHARMACY-BASED DRUG TAKE-BACK - WEBINAR RECORDING
Pharmacies can play an important role in providing their communities access to convenient drug take-back programs, particularly in rural areas. Not only do drug take-back programs provide an easy, safe, and effective way to reduce the public health and environmental impacts of leftover drugs, they a...

Drug Take-Back: Rural Areas to Fight Drug Abuse, Water Impacts-Webinar Recording
DRUG TAKE-BACK: RURAL AREAS TO FIGHT DRUG ABUSE, WATER IMPACTS-WEBINAR RECORDING
Each year, over $1 billion worth of leftover drugs are thrown in the trash, flushed, or relegated to medicine cabinets. Removing unwanted prescription drugs from the home reduces their availability to addicts, children, and pets, and prevents them from being thrown in the garbage or down the drain w...

How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances
HOW TO SURVIVE A DEA INSPECTION - VETERINARY MEDICINE AND CONTROLLED SUBSTANCES
The Drug Enforcement Administration (“DEA”) through their Office of Diversion Control (“Diversion”) is responsible for enforcing federal laws and DEA regulations pertaining to the administering, dispensing and prescribing of controlled substances by practitioners practicing veterinary medicine in a ...

Pharmaceutical Manufacturing Troubleshooting
PHARMACEUTICAL MANUFACTURING TROUBLESHOOTING
In this session, the presenter will review classic pharmaceutical manufacturing problems for their lessons about trouble shooting in general. Specific manufacturing issues will be analyzed to see how decisions were made and how they affected the outcomes.

Compliance with Brexit
COMPLIANCE WITH BREXIT'S IMPACT ON THE GLOBAL PHARMACEUTICAL INDUSTRY
"It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry", said the UK’s Prime Minister Theresa May (1). It is important to consider what’s ahead for the industry, which will allow both UK and global drug development to prosper after Brexit.

Classifying Medical Devices - US and EU
CLASSIFYING MEDICAL DEVICES - US AND EU
The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assu...

Risk-based Approach to Biopharmaceutical Method Transfers
RISK-BASED APPROACH TO BIOPHARMACEUTICAL METHOD TRANSFERS
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it diffic...

Implementing a Modern Pharmaceutical Quality System
IMPLEMENTING A MODERN PHARMACEUTICAL QUALITY SYSTEM
In 2008, the International Conference on Harmonization published the ICH tripartite guideline titled, Pharmaceutical Quality System Q10. The guideline describes a model for an effective pharmaceutical quality system. As quoted in the document, “ICH Q10 describes one comprehensive model for an effect...

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists
SELECTION AND AUDITING OF ANALYTICAL CONTRACT LABORATORIES: BEST PRACTICES FOR PHARMACEUTICAL SCIENTISTS
This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducti...

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing
CREATING FDA-COMPLIANT MICROBIAL CONTAMINATION CONTROL PROGRAM FOR BIOPHARMACEUTICAL MANUFACTURING
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.

PRACTICAL ESSENTIALS OF PHARMACEUTICAL EXCIPIENTS
PRACTICAL ESSENTIALS OF PHARMACEUTICAL EXCIPIENTS
Excipients, sometimes referred to as inactive or inert ingredients, are materials used every day in compounding and play a crucial role in the functionality and efficacy of many preparations.

STERILE CLEANROOM DESIGN: NON-HAZARDOUS DRUG COMPOUNDING
STERILE CLEANROOM DESIGN: NON-HAZARDOUS DRUG COMPOUNDING
This webinar outlines the structural, functional, and operational design parameters for a sterile non-hazardous drug compounding cleanroom as required by USP General Chapter <797> (proposed). Cleanroom design illustrations for garbing, pre-sterilization.

Key signaling pathways in cancer: Emerging trends in immunometabolism
KEY SIGNALING PATHWAYS IN CANCER: EMERGING TRENDS IN IMMUNOMETABOLISM
Immune cells divide rapidly when mounting an immune response against a pathogen, for example, or when initiating a wound-healing response. To accommodate the increased energy requirements to mount the immune response.

Deciphering cancer: The intersection of epigenetics, metabolism, and tumorigenesis
DECIPHERING CANCER: THE INTERSECTION OF EPIGENETICS, METABOLISM, AND TUMORIGENESIS
Epigenetic modifications to DNA and histone proteins are known to regulate metabolic gene expression, which in turn impacts metabolite levels.

Addressing the Challenges of Low Clearance in Drug Discovery
ADDRESSING THE CHALLENGES OF LOW CLEARANCE IN DRUG DISCOVERY
Li Di has about 20 years of experience in the pharmaceutical indus­try including Pfizer, Wyeth and Syntex. She is currently an associate research fellow at Pfizer, Groton, CT. Her research interests include the areas of drug metabo­lism, pharmacokinetics, drug-drug interactions, absorption, transpor...

Japan CTD: Bracketing Strategies for the Manufacturing Process
JAPAN CTD: BRACKETING STRATEGIES FOR THE MANUFACTURING PROCESS
Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of academic and industrial experience.

Epigenetic Analysis Using Highly Validated Antibodies and Optimized ChIP Assays
EPIGENETIC ANALYSIS USING HIGHLY VALIDATED ANTIBODIES AND OPTIMIZED CHIP ASSAYS
Research in the field of epigenetics has grown at a rapid pace since the discovery of the first histone acetyltransferase enzymes 18 years ago. Since then, significant advances have been made in our understanding of the basic mechanisms of epigenetics (histone acetylation,.

Pharmacovigilance: Review and Pragmatic Considerations for Scientific Literature
PHARMACOVIGILANCE: REVIEW AND PRAGMATIC CONSIDERATIONS FOR SCIENTIFIC LITERATURE
To meet good pharmacovigilance practices, regulatory authorities expect Marketing Authorisation Holders of medicinal products to review the scientific literature for their product portfolio on a weekly basis.

Orphan Drug & Rare Disease Development: Understanding the European and US Regulatory Landscape
ORPHAN DRUG & RARE DISEASE DEVELOPMENT: UNDERSTANDING THE EUROPEAN AND US REGULATORY LANDSCAPE
Today more than ever researchers are focused on providing care for diseases that in the past have remained neglected. The National Institute of Health (NIH) has identified around 7,000 rare diseases, many of which are of genetic origin.

Enrollment Is Open, But We Have No Drug!  Making Lemons into Lemonade
ENROLLMENT IS OPEN, BUT WE HAVE NO DRUG! MAKING LEMONS INTO LEMONADE
When a sponsor company announced during the investigator’s meeting that manufacturing had been suspended and there was no drug available to begin enrollment the next day as planned, a Phase 2 respiratory study could have been completely lost.

An Endogenous Solute Uptake Pathway for Oral Peptide Drug Delivery
AN ENDOGENOUS SOLUTE UPTAKE PATHWAY FOR ORAL PEPTIDE DRUG DELIVERY
We have developed an approach to improve tight junction (TJ) permeability of therapeutic proteins using a small membrane-permeable peptide (640 peptide) to induce an increase in phosphorylated myosin light.

Emerging Biopharma: Designing Smarter, More Predictable Clinical Trials
EMERGING BIOPHARMA: DESIGNING SMARTER, MORE PREDICTABLE CLINICAL TRIALS
For biotech companies, success can be transformational. But the path is often paved with unique challenges, including constrained budgets and limited internal resources.

Emerging Role of Biomarkers in Improving the Success Rate of Early Oncology Drug Development
EMERGING ROLE OF BIOMARKERS IN IMPROVING THE SUCCESS RATE OF EARLY ONCOLOGY DRUG DEVELOPMENT
This webinar is intended to help Oncology drug developers explore Biomarkers in the design of clinical trials. Many new anticancer drugs target proteins encoded by genes with driver somatic mutations, thus exhibiting efficacy only in a subgroup of patients whose tumors harbor these mutations like KR...

Evolution of Flow Cytometry Guidelines for Drug Development and Clinical Testing
EVOLUTION OF FLOW CYTOMETRY GUIDELINES FOR DRUG DEVELOPMENT AND CLINICAL TESTING
Flow cytometry is the leading technology for cellular analysis because it allows for the simultaneous detection of numerous characteristics on individual cells.

Bioenhancement of Poorly Water Soluble Drugs: Challenges and Opportunities for Drug Development
BIOENHANCEMENT OF POORLY WATER SOLUBLE DRUGS: CHALLENGES AND OPPORTUNITIES FOR DRUG DEVELOPMENT
The absorption and bioavailability of drugs can be limited by their solubility, dissolution rate, permeability or instability. The poor solubility of new chemical entities (NCEs) is one of the most frequent and greatest challenges to formulation scientists in the development of oral solid dosage for...

A preview into PharmaPendium’s upcoming new user interface
A PREVIEW INTO PHARMAPENDIUM’S UPCOMING NEW USER INTERFACE
On February 23, 2015, a new user interface will be launched for PharmaPendium. Join this 15 to 20 minute session to preview the new interface and to see how this may impact your current workflows for drug safety and efficacy assessments.

Pathway Studio’s Cell-Centered Database for Immunology and Cancer Research
PATHWAY STUDIO’S CELL-CENTERED DATABASE FOR IMMUNOLOGY AND CANCER RESEARCH
Determining cellular mechanisms of diseases is a crucial requirement for understanding the causes and progression of diseases, predicting outcomes, and developing new treatments.

Mobilizing Informational Resources for Rare Disease with Elsevier
MOBILIZING INFORMATIONAL RESOURCES FOR RARE DISEASE WITH ELSEVIER'S TEXT MINING
You are invited to join us as Dr. Maria Shkrob discusses how Elsevier is collaborating with Findacure to create an information portal that will help find new treatments and streamline information exchange. Dr. Shkrob presents how the knowledgebase was created and demonstrates its utility.

Legal Aspects of Doing Pharma Business in Ukraine: Review of 2016
LEGAL ASPECTS OF DOING PHARMA BUSINESS IN UKRAINE: REVIEW OF 2016
Legal Alliance Company, one of the leading law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries, invites you to participate in a FREE English language webinar «LEGAL ASPECTS OF DOING PHARMA BUSINESS IN UKRAINE: REVIEW OF 2016». You will neve...

Powder Handling and Characterization for Design of Pharmaceutical Manufacturing Processes
POWDER HANDLING AND CHARACTERIZATION FOR DESIGN OF PHARMACEUTICAL MANUFACTURING PROCESSES
While powder handling and processing is common in pharmaceutical manufacturing, multiple challenges, for example jamming of hoppers, sub-standard blending performance, weight variability of final products, and process scale-up failures, are encountered during production due to lack of fundamental un...

Process Analytical Technology (PAT): The “Official” Language of Pharmaceutical Outsourcing
PROCESS ANALYTICAL TECHNOLOGY (PAT): THE “OFFICIAL” LANGUAGE OF PHARMACEUTICAL OUTSOURCING
Drug Product Manufacturing - Real-time batch control of high-shear wet granulation using in-process particle monitoring. Process Safety - Standardized thermal analysis using reaction calorimetry to ensure safe process scale-up Active Pharmaceutical Ingredient (API) Manufacturing - In situ reaction m...

Thermal Analysis of Organic Compounds
THERMAL ANALYSIS OF ORGANIC COMPOUNDS
The field of organic chemistry focuses on the synthesis, purification and qualification of organic compounds. Thermal analysis can be used to study, predict and check the many processes in the production of organic compounds.

Building Green Pharmaceutical Manufacturing on a Foundation of PAT and QbD
BUILDING GREEN PHARMACEUTICAL MANUFACTURING ON A FOUNDATION OF PAT AND QBD
In this free webinar, Paul Thomas, Senior Editor of Pharmaceutical Manufacturing, presents an overview of how the Process Analytical Technology (PAT) Framework and Green Manufacturing initiatives complement and reinforce each other in the pursuit of research and manufacturing efficiency in the pharm...

Thermal Analysis of Medical Materials
THERMAL ANALYSIS OF MEDICAL MATERIALS
The health care industry will continue to drive research in the field of medical materials, including the development of new materials, processing techniques and innovative product design. Thermal analysis techniques like DSC, TGA, TMA, and DMA are ideal for characterizing such materials.

Pharmaceutical Drug Substance Crystallisation
PHARMACEUTICAL DRUG SUBSTANCE CRYSTALLISATION
This presentation describes a case study of an Active Pharmaceutical Ingredient (API) where the crystals have a high propensity to float in their mother liquors during crystallisation and filtration.

Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies
GOOD MANUFACTURING PRACTICES (GMPS) FOR PHASE I INVESTIGATIONAL DRUGS / CLINICAL STUDIES
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally done in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.

Bio-Relevant Drug Dissolution Testing: A New Simple and Practical Approach
BIO-RELEVANT DRUG DISSOLUTION TESTING: A NEW SIMPLE AND PRACTICAL APPROACH
This training program will highlight the current difficulties in conducting the dissolution tests, and then providing a simple and practical solution so that products could be evaluated appropriately and efficiently.

Development and validation of pharmacokinetic (PK) and immunogenicity assays supporting demonstration of biosimilarity
DEVELOPMENT AND VALIDATION OF PHARMACOKINETIC (PK) AND IMMUNOGENICITY ASSAYS SUPPORTING DEMONSTRATION OF BIOSIMILARITY
For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product compared to the reference product.

Extractables and Leachables Assessment for Inhalation Drug Products
EXTRACTABLES AND LEACHABLES ASSESSMENT FOR INHALATION DRUG PRODUCTS
OINDP product formulations (which is primarily a propellant including an organic solvent) have a high potential for the leaching of substances from the inhalation device components.

Formulation Strategies for Orally Inhaled and Nasal Drug Products
FORMULATION STRATEGIES FOR ORALLY INHALED AND NASAL DRUG PRODUCTS
Orally Inhaled and Nasal Drug Products (OINDPs) provide an effective delivery route for both topical and systemic drug delivery of both small and large molecules. The more complex nature of these products and delivery systems do however provide unique challenges for both product formulation and anal...

Using the Cloud to Meet Pharmacovigilance Requirements and Maintain Global Compliance
USING THE CLOUD TO MEET PHARMACOVIGILANCE REQUIREMENTS AND MAINTAIN GLOBAL COMPLIANCE
Keeping up with the increasing and evolving safety and pharmacovigilance obligations around the globe can be a major challenge. In this webinar, the speaker will discuss upcoming changes in global drug safety regulatory requirements and will demonstrate how Bioclinica's drug safety regulatory intell...

The Business of Drug Discovery and Development
THE BUSINESS OF DRUG DISCOVERY AND DEVELOPMENT
The lecture series and related texts are designed to provide an understanding of the landscape, issues and strategy of drug discovery and development. They are aimed at business persons and scientists who wish to learn or improve how their skills can be applied to biobusiness

The State of Drug Development
THE STATE OF DRUG DEVELOPMENT
BioPharma Dive and Catalent present a panel-style discussion on the trends and challenges of drug development. Our expert speakers will discus: Biosimilars and Biologics development and future FDA regulations.

The Practical Application of Home Healthcare
THE PRACTICAL APPLICATION OF HOME HEALTHCARE
Stuart Redding, Vice President of Global Business Development at MRN and Dave Spillet, Key Account Director at World Courier share their experiences of setting up and implementing the home care model, taking into account varying international regulation.

The Power of Foresight: Improving Drug Development Performance through Optimized Protocol Design
THE POWER OF FORESIGHT: IMPROVING DRUG DEVELOPMENT PERFORMANCE THROUGH OPTIMIZED PROTOCOL DESIGN
Results from The Tufts Center for the Study of Drug Development studies show that the executional feasibility of protocol designs is becoming increasingly complex and that complexity is highly correlated with poor clinical trial performance, cost, and efficiency.

The Power of Foresight: Improving Drug Development Performance through Optimized Protocol Design
THE POWER OF FORESIGHT: IMPROVING DRUG DEVELOPMENT PERFORMANCE THROUGH OPTIMIZED PROTOCOL DESIGN
Results from The Tufts Center for the Study of Drug Development studies show that the executional feasibility of protocol designs is becoming increasingly complex and that complexity is highly correlated with poor clinical trial performance, cost, and efficiency.

Necessity is the Mother of Invention: The Impetus for Observational Research in Orphan Drug Development
NECESSITY IS THE MOTHER OF INVENTION: THE IMPETUS FOR OBSERVATIONAL RESEARCH IN ORPHAN DRUG DEVELOPMENT
The push for innovation in orphan disease research is driven by an accelerated research and development cycle, patient and family concerns for timely product access during the development process as well as following product registration, and the emergence of a regulatory and reimbursement environme...

Rapid and Efficient Fragment Screening of Influenza and Ebola Viral Targets to Enable Novel Drug Discovery
RAPID AND EFFICIENT FRAGMENT SCREENING OF INFLUENZA AND EBOLA VIRAL TARGETS TO ENABLE NOVEL DRUG DISCOVERY
This webinar will discuss the use of ligand-observed NMR techniques for rapid and efficient fragment screening of viral targets. Fragment screening was performed on two different viral proteins, an H1N1 Influenza A virus polymerase acid protein C-terminal domain (PA-CTD) and the Ebola virus matrix p...

Part B Drug Payment Change: Understanding the Implications for Pharma
PART B DRUG PAYMENT CHANGE: UNDERSTANDING THE IMPLICATIONS FOR PHARMA
Over the last six months, the Centers for Medicare & Medicaid Services (CMS) have hinted at changes in drug pricing, driven by their assertion that physician-drugs administered under Medicare Part B were potentially incentivizing providers to use more expensive medications.

Assessing Cognitive Safety of Drugs in Clinical Development
ASSESSING COGNITIVE SAFETY OF DRUGS IN CLINICAL DEVELOPMENT
Cognitive impairment is increasingly recognized as a serious potential side effect of medication – both for central nervous system (CNS) and non-CNS compounds. Despite concerns voiced by physicians, regulators and consumers many drug development programs do not incorporate objective and sensitive co...

How to Reduce the Time and Cost for Optimizing Drug Product Formulations with RapidFACT® (Rapid Formulation development And Clinical Testing)
HOW TO REDUCE THE TIME AND COST FOR OPTIMIZING DRUG PRODUCT FORMULATIONS WITH RAPIDFACT® (RAPID FORMULATION DEVELOPMENT AND CLINICAL TESTING)
RapidFACT accelerates the process for developing and optimizing drug product formulations. Real-time flexibility within the clinical study allows product compositions to be varied and performance attributes optimized in response to arising data.

Applying Advanced Informatics to Accelerate Drug Development in Diabetic Nephropathy
APPLYING ADVANCED INFORMATICS TO ACCELERATE DRUG DEVELOPMENT IN DIABETIC NEPHROPATHY
Diabetes and hypertension frequently coexist and account for much of the increased global burden of kidney disease. There are multiple drugs in development to reduce progression of diabetic nephropathy, but there are well-recognized challenges associated with conduct of later phase clinical trials i...

No Opportunity Unturned: Optimizing Orphan Drug Development
NO OPPORTUNITY UNTURNED: OPTIMIZING ORPHAN DRUG DEVELOPMENT
Regulations supporting orphan drug research have been evolving for more than 20 years, providing incentives and guidance for development of potentially promising drugs to treat rare indications. More recently, with global attention and advocacy focused on improving treatments in these areas of unmet...

Risk Sharing Q&A Prove the true effectiveness of your medicines and accelerate access
RISK SHARING Q&A PROVE THE TRUE EFFECTIVENESS OF YOUR MEDICINES AND ACCELERATE ACCESS
Listen to this Q&A session with Driss Berdaï, Member of the Transparency Committee at the French HAS, Maria Kubin, Vice President of Global Market Access at Bayer, and Alexander Natz, Director General of EUCOPE, who share their advice on how to gain a complete understanding of how to implement a suc...

The Access Challenges and its Impact on Pharma
THE ACCESS CHALLENGES AND ITS IMPACT ON PHARMA'S COMMERCIAL TEAMS
Integrating access and commercial team’s functions is essential to drive forward commercial success. eyeforpharma bringing you a panel of experts to discuss how to engage and motivate your commercial and access teams.

Prove it: Measure and Communicate the Value of Patient Centricity in your Company
PROVE IT: MEASURE AND COMMUNICATE THE VALUE OF PATIENT CENTRICITY IN YOUR COMPANY
In this webinar Sanofi, Merck, Grünenthal and Roche give their expert insights on how a ‘patients first’ business model not only significantly improves clinical outcomes, but also has a positive impact on profits.

Characterizing Pharmaceuticals Utilizing Chemical Imaging
CHARACTERIZING PHARMACEUTICALS UTILIZING CHEMICAL IMAGING
Chemical imaging is an analytical technique that combines digital imaging with spectroscopy to characterize materials in various drug delivery systems, including nasal spray and inhalation products, semi-solids, solids, transdermal and controlled release systems, as well as medical devices.

Pharmaceutical Investigations Webinar Series
PHARMACEUTICAL INVESTIGATIONS WEBINAR SERIES
This webinar series is designed for laboratory and manufacturing personnel that are responsible for ensuring quality assurance and quality control of processes in the manufacturing of pharmaceuticals and medical devices.

Laboratory Methods for Failure Analysis of Pharmaceutical Products
LABORATORY METHODS FOR FAILURE ANALYSIS OF PHARMACEUTICAL PRODUCTS
Failures in pharmaceutical products may range from issues with delamination and packaging failures to polymorphs arising in the pharmaceutical product.

Determining the Source of Contaminants and Foreign Particulate Matter in a Pharmaceutical Manufacturing Process
DETERMINING THE SOURCE OF CONTAMINANTS AND FOREIGN PARTICULATE MATTER IN A PHARMACEUTICAL MANUFACTURING PROCESS
When contaminants or foreign particulate matter arise in a pharmaceutical manufacturing process, the FDA requires a full investigation to identify the material and determine where it has come from. However, determining the source of these materials may not be straightforward.

Ensure Quality Inhalation Products with Wear Debris Analysis of Medical Devices
ENSURE QUALITY INHALATION PRODUCTS WITH WEAR DEBRIS ANALYSIS OF MEDICAL DEVICES
Medical devices such as inhalers tend to experience wear debris, which can cause a number of quality issues. Characteristics of wear debris, including particle size and shape distribution, number of particles and chemistry is important to assess for specific medical devices.

Working to Address the FDA Critical Path Opportunity for Generic Nasal Spray Suspensions
WORKING TO ADDRESS THE FDA CRITICAL PATH OPPORTUNITY FOR GENERIC NASAL SPRAY SUSPENSIONS
The FDA stated in their 2007 Critical Path Opportunity for Generic Drugs that “If the drug particle size distribution of test and reference products can be demonstrated to be equivalent, then nasal spray suspensions could be treated like nasal spray solutions.

In Depth Analysis of Particle Contamination for Parenteral Drug Products
IN DEPTH ANALYSIS OF PARTICLE CONTAMINATION FOR PARENTERAL DRUG PRODUCTS
During this webinar, our presenters identified commonly found contaminants in parenteral drug products, how these contaminants are introduced into the manufacturing process.

In Depth Analysis of Particle Contamination for Inhalable Drug Products
IN DEPTH ANALYSIS OF PARTICLE CONTAMINATION FOR INHALABLE DRUG PRODUCTS
This webinar was designed for individuals involved in the manufacturing of inhalable drug products. During this webinar, our presenter provided examples of commonly found contaminants in inhalable drug products and how these contaminants are introduced into the manufacturing process.

In Depth Analysis of Particle Contamination for Tablet and Semi-Solid Drug Products
IN DEPTH ANALYSIS OF PARTICLE CONTAMINATION FOR TABLET AND SEMI-SOLID DRUG PRODUCTS
This webinar was designed for professionals (e.g. Quality Control, Industrial Engineers) involved in the production and development of tablet and semi-solid drug products. During this webinar, our presenters provided examples of commonly found particle contamination in tablet and semi-solid drug pr...

Value of Raman Analysis in Pharmaceutical Investigations
VALUE OF RAMAN ANALYSIS IN PHARMACEUTICAL INVESTIGATIONS
Raman analysis is an analytical technique growing in popularity for analysis of pharmaceutical drug products. This non-destructive test requires little to no sample preparation and provides confirmatory spectral results similar to FTIR spectroscopy.

Helping India-based Generic Pharmaceutical Drug Manufacturers Reach Bioequivalence with Raman Chemical Imaging
HELPING INDIA-BASED GENERIC PHARMACEUTICAL DRUG MANUFACTURERS REACH BIOEQUIVALENCE WITH RAMAN CHEMICAL IMAGING
This webinar offers attendees insight into how chemically specific analysis using Raman Chemical Imaging (RCI) and other cGMP-compliant analytical services at Gateway Analytical can provide the detailed information needed to get a drug product to reach bioequivalence faster, in addition to providing...

Hair as a Pharmaceutical Contaminant: How It Is Identified, and How We Can Tell Where It Originated
HAIR AS A PHARMACEUTICAL CONTAMINANT: HOW IT IS IDENTIFIED, AND HOW WE CAN TELL WHERE IT ORIGINATED
Foreign particulate in drug products originate from a variety of sources. Such sources can include machinery used in drug manufacturing, drug packaging components, cleaning utensils and products, personnel wearing personal protective equipment (PPE) and laboratory surfaces.

Orphan Drugs: Making Rare Disease Rarer
ORPHAN DRUGS: MAKING RARE DISEASE RARER
The signing of FDASIA by President Obama in July reinforces the country's commitment to fostering innovation for rare diseases. With a record 460 medicines in late-stage clinical trials, biopharmaceutical companies have embraced rare disease medicine and are rapidly developing the pipeline with hope...

Drug Development in the Cloud: Do Hosted E-Clinical Solutions Make Sense?
DRUG DEVELOPMENT IN THE CLOUD: DO HOSTED E-CLINICAL SOLUTIONS MAKE SENSE?
Using a hosted e-clinical cloud solution in drug development has a number of advantages. In preclinical and clinical trials, the consistency of data entry can be controlled by using templates, and the results can be collected remotely from even the smallest site and analyzed in real time.

how are the top 20 pharma companies using social media?
HOW ARE THE TOP 20 PHARMA COMPANIES USING SOCIAL MEDIA?
Over the past decade, the rise of social media has caused a huge shift in the way businesses interact with customers. Pharma, often thought of as a guarded industry when it comes to social, is upping its game and using social to reach a wide audience including patients and healthcare professionals.

HIV, HEPATITIS AND OVERDOSE AMONG DRUG USERS: THE HEALTH DEPARTMENT ROLE IN AN EFFECTIVE RESPONSE
HIV, HEPATITIS AND OVERDOSE AMONG DRUG USERS: THE HEALTH DEPARTMENT ROLE IN AN EFFECTIVE RESPONSE
The goal of the meeting was to provide a venue for health department HIV and viral hepatitis staff to examine their efforts to reduce HIV and HCV transmission and overdose among persons who inject drugs, and to develop plans to expand their efforts through the framework of drug user health.

2014 NATIONAL AIDS DRUG ASSISTANCE PROGRAM (ADAP) TECHINCAL ASSISTANCE MEETING
2014 NATIONAL AIDS DRUG ASSISTANCE PROGRAM (ADAP) TECHINCAL ASSISTANCE MEETING
This annual meeting serves as an opportunity for health department staff to learn, discuss and share experiences about the AIDS Drug Assistance Programs in their jurisdiction.

HIGH IMPACT PREVENTION FOR PEOPLE WHO INJECT DRUGS
HIGH IMPACT PREVENTION FOR PEOPLE WHO INJECT DRUGS
NASTAD’s June 2015 webinar highlighted examples of health department HIV and viral hepatitis programming and partnerships that provide effective High Impact Prevention for people who inject drugs (PWID). The webinar featured presenters from the California Department of Public Health and the New Mexi...

NAVIGATING MODIFIED ADJUSTED GROSS INCOME (MAGI) AND PROGRAM ELIGIBILITY: CONSIDERATIONS FOR AIDS DRUG ASSISTANCE PROGRAMS (ADAP)
NAVIGATING MODIFIED ADJUSTED GROSS INCOME (MAGI) AND PROGRAM ELIGIBILITY: CONSIDERATIONS FOR AIDS DRUG ASSISTANCE PROGRAMS (ADAP)
This webinar included an in-depth explanation of modified adjusted gross income (MAGI) and its impact on Qualified Health Plan (QHP) eligibility. The webinar also explored opportunities and challenges associated with aligning program eligibility and recertification with MAGI, and briefly reviewed op...

CALCULATING VALUE TO ACHIEVE HIV PREVENTION PROGRAM SUSTAINABILITY
CALCULATING VALUE TO ACHIEVE HIV PREVENTION PROGRAM SUSTAINABILITY
Developed in collaboration with Bannon Consulting, this two-part webinar will guide Health Departments (HD) on how to assist HIV providers in answering key questions to determine their sustainability strategy. In particular, the webinars will help HD participants gain a deeper .

NAVIGATING CLIENT FEDERAL TAX FILINGS: CONSIDERATIONS FOR AIDS DRUG ASSISTANCE PROGRAMS
NAVIGATING CLIENT FEDERAL TAX FILINGS: CONSIDERATIONS FOR AIDS DRUG ASSISTANCE PROGRAMS
This webinar is a part of NASTAD’s cooperative agreement with the Health Resources and Services Administration (HRSA) and included discussion of opportunities to support clients to maintain access to Qualified Health Plans (QHPs) through compliance with the Affordable Care Act’s tax filing requireme...

DEPARTMENTS TO ADVANCE DRUG USER HEALTH: RECOMMENDED ACTIONS FROM CDC’S VITAL SIGNS AND BEYOND
DEPARTMENTS TO ADVANCE DRUG USER HEALTH: RECOMMENDED ACTIONS FROM CDC’S VITAL SIGNS AND BEYOND
NASTAD hosted a webinar detailing the Centers for Disease Control and Prevention (CDC) Vital Signs report on HIV and Injection Drug Use (IDU), comprehensive and inclusive approaches to advancing drug user health, and the important role that health departments must play to increase access to syringe ...

PrEP Drug Assistance Programs Webinar Recording
PREP DRUG ASSISTANCE PROGRAMS WEBINAR RECORDING
NASTAD is a non-partisan non-profit association that represents public health officials who administer HIV and hepatitis health care.

Chinese serialization regulations for pharmaceutical track & trace - webinar
CHINESE SERIALIZATION REGULATIONS FOR PHARMACEUTICAL TRACK & TRACE - WEBINAR
Learn about the pharmaceutical Track & Trace requirements for the chinese market and get a checklist of the most critical points when it comes to selecting the right serialization equipment manufacturer and service provider for your global roll-out.

Particle Engineering in Pharmaceutical Solids Processing
PARTICLE ENGINEERING IN PHARMACEUTICAL SOLIDS PROCESSING
This webinar presented by Dr Daryl Williams from Imperial College London reviews the surface energy and surface energy heterogeneity of crystalline solids, methods for the measurement of surface energy, effects of milling on powder surface energy, adhesion and cohesion on powder mixtures, crystal ha...

LIMS and MODA-EM™ Solution for Pharmaceutical Manufacturing Quality Control
LIMS AND MODA-EM™ SOLUTION FOR PHARMACEUTICAL MANUFACTURING QUALITY CONTROL
Watch our archived webinar and learn how the full integration of the LabVantage LIMS and the MODA-EM™ Solution provides benefits to pharmaceutical quality control.

NETZSCH Webinar "Pharmaceutical Processing at its Finest"
NETZSCH WEBINAR "PHARMACEUTICAL PROCESSING AT ITS FINEST"
Pharmaceutical manufacturing is moving into the Nanometer particle size range to enhance API solubility and improve performance. NETZSCH's new DeltaVita® fine media mill is designed specifically for the particular needs of pharmaceutical processing in batch sizes from 15 ml to 4000 liters. Pilot sca...

ARC and Siemens Webinar on Efficient Engineering and Operations of a Pharmaceutical Plant
ARC AND SIEMENS WEBINAR ON EFFICIENT ENGINEERING AND OPERATIONS OF A PHARMACEUTICAL PLANT
This joint Webinar is presented to you by ARC Advisory Group, Siemens and Novartis. Comos, a Siemens technology is key to Novartis Pharmaceutical Plant operations and engineering. The speakers include Dr. Valentijn de Leeuw - ARC Advisory Group Analyst, Mr Christoph Jauslin - Head of Engineering IT ...

Preparing for EU Falsified Medicines Directive: On-Demand Webinar
PREPARING FOR EU FALSIFIED MEDICINES DIRECTIVE: ON-DEMAND WEBINAR
The European Union's Falsified Medicines Directive (FMD) has an implementation deadline of February 9, 2019. Because the EU is one of the largest global markets, it is crucial for pharmaceutical companies and their CMO/CPO partners start NOW in understanding the extensive serialization, compliance ...

Brazil Pharmaceutical Serialization and Tracking Compliance: On-Demand Webinar
BRAZIL PHARMACEUTICAL SERIALIZATION AND TRACKING COMPLIANCE: ON-DEMAND WEBINAR
ANVISA, the Brazilian Health Surveillance Agency, has adopted a final resolution on pharmaceutical serialization and drug tracking and new drug serialization regulations phase in beginning in 2015. What are the business, IT and operational requirements for your company and your trading partners and ...

DSCSA Compliance for Pharmacies: On-Demand Webinar
DSCSA COMPLIANCE FOR PHARMACIES: ON-DEMAND WEBINAR
By July 1 2015, every pharmacy, clinic, hospital, physician, and long-term care facility that dispenses prescription medicine in the US must comply with DSCSA. Do you understand what that means for your business? And are you ready.

When small becomes big: orphan medicines, advances, access and affordability
WHEN SMALL BECOMES BIG: ORPHAN MEDICINES, ADVANCES, ACCESS AND AFFORDABILITY
Over the past few years there has been a shift in the European pharmaceutical market landscape, with a rise in specialty medicines for diseases with narrow patient populations. Indeed, QuintilesIMS forecasts that, between 2013 and 2018, 94% of list price value growth will be in specialty medicines –...

Webinar on Pharmacovigilance and Drug Safety
WEBINAR ON PHARMACOVIGILANCE AND DRUG SAFETY
One of the reasons for good clinical practice (GCP) is to protect the subjects in a research trial. In all research the subjects’ well-being should be paramount Safety checks, procedures, and reporting are fundamental to any research study involving human subjects.

Webinar on Combination Drug/Device Products cGMPs – Final Rule
WEBINAR ON COMBINATION DRUG/DEVICE PRODUCTS CGMPS – FINAL RULE
This training on combination product regulations will evaluate the chief areas of concern or change in the new cGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.

Webinar on Drug Master Files: New Implications under GDUFA
WEBINAR ON DRUG MASTER FILES: NEW IMPLICATIONS UNDER GDUFA
The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detaile...

The FDA Guidance on the Assessment of Abuse Potential of Drugs – A Critical Review
THE FDA GUIDANCE ON THE ASSESSMENT OF ABUSE POTENTIAL OF DRUGS – A CRITICAL REVIEW
In January 2017, the FDA finalized their guidance for industry reviewing the requirements for the assessment of abuse potential of drugs. As stated in the guidance, drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce specif...

Global Outlook for Medicines through 2021
GLOBAL OUTLOOK FOR MEDICINES THROUGH 2021
During the webinar, they will share an updated perspective on - and the implications of - the use of new and existing medicines as well as spending levels and access constraints through 2021. The report focuses on a global view of the markets for all types of pharmaceuticals, including small and lar...

Good Manufacturing Practices for Aseptic Filling of Biopharmaceuticals
GOOD MANUFACTURING PRACTICES FOR ASEPTIC FILLING OF BIOPHARMACEUTICALS
Sterilization is a critical process that packaging components undergo when processed via aseptic conditions. There are various sterilization processes and variables that are utilized to remove or destroy micro-organisms so that the end drug product is free of contagious hazards in all respects. The ...

Literature Management for Pharmacovigilance - Outsource or in-house solution
LITERATURE MANAGEMENT FOR PHARMACOVIGILANCE - OUTSOURCE OR IN-HOUSE SOLUTION
Pharmaceutical companies are required to screen scientific literature on a regular basis and this comes with many challenges, such as handling large amounts of data, building search strings and integrating EMA MLM results.

Strategies in Pharmacovigilance and Drug Safety
STRATEGIES IN PHARMACOVIGILANCE AND DRUG SAFETY
Over the past few years, insurers and regulatory agencies such as the FDA have become increasingly involved in collecting and analyzing reports about adverse events related to drugs. At the same time, the methods patients can use to report these events have expanded well beyond doctors and regulator...