Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned

Bioclinica

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 availability of the necessary parts of the system to implement pharmacovigilance on time by first-time marketing authorization holders.
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Spotlight

The artificial intelligence (AI) healthcare market is expected reach $6.6 billion by 2021, representing a compound annual growth rate (CAGR) of 40 percent over the next five years, according to a report from Accenture. AI in health represents a collection of multiple technologies enabling machines to sense, comprehend, act and learn so they can perform administrative and clinical healthcare functions. Unlike legacy technologies that are only algorithms/ tools that complement a human, health AI today can truly augment human activity.


OTHER ON-DEMAND WEBINARS

PRACTICAL ESSENTIALS OF PHARMACEUTICAL EXCIPIENTS

LP3 Network

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.
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Risk-based Approach to Biopharmaceutical Method Transfers

ComplianceOnline

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 difficult to transfer methods and can result in a high transfer failure rate.
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PharmaPendium Efficacy Module; Comparative efficacy endpoints, indications, and trial design data for drug development

Elsevier

Learn how to leverage data extracted from FDA and EMA Approval Documents to help streamline clinical trial designs, aid in translational model selection and support regulatory reviews. The new Efficacy Module for PharmaPendium addresses Phase I and Phase II questions such as, what is the optimal sample size and what endpoints were approved for a specific indication like breast cancer. This use case webinar will highlight how quickly comparative efficacy data can be retrieved and when coupled with data from other modules, helps provide a more comprehensive efficacy and safety assessment.
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Training Pharmaceutical Quality Assurance Teams For Success

Q1 Productions

Maintaining a rigorous level of quality assurance in pharmaceutical manufacturing is of utmost importance, which in turn creates a tremendous demand for adequate training activities. Quality assurance teams have been given the difficult task of meeting ever increasing regulatory demands while maintaining the highest level of product quality, and a well-rounded training program can ensure these tasks are not only met, but exceeded.
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Spotlight

The artificial intelligence (AI) healthcare market is expected reach $6.6 billion by 2021, representing a compound annual growth rate (CAGR) of 40 percent over the next five years, according to a report from Accenture. AI in health represents a collection of multiple technologies enabling machines to sense, comprehend, act and learn so they can perform administrative and clinical healthcare functions. Unlike legacy technologies that are only algorithms/ tools that complement a human, health AI today can truly augment human activity.

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