IMPACT ON COMBINATION PRODUCTS AND COMPANION DIAGNOSTICS

July 19, 2019

With the end of the Medical Device Regulation’s (MDR) transition period looming (May 26th, 2020), manufacturers of drug device combination products or companion diagnostics are under heightened time pressure to comply with the new Regulation. Any company manufacturing or distributing these products risks losing European market access unless their products meet the latest regulatory requirements.

Spotlight

Asia Pharmaceutical Industries

ASIA Pharmaceutical Industries is one of the pioneering pharmaceutical companies in Syria and the Middle East. Within two decades, a dedicated and highly qualified team of scientists and healthcare professionals has developed a world-class company that has been awarded international quality certificates: cGMPs, ISO 9001, ISO 14001 as well as the OHSAS 18001.

OTHER WHITEPAPERS
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Regenerative Medicine

whitePaper | September 16, 2022

T wice a year, we survey the cell and gene therapy landscape and ARM’s initiatives to advance the sector and provide an update to our members.

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Achieving diversity, equity and inclusion in clinical trials

whitePaper | April 26, 2022

The prevalence of communicable and non-communicable diseases are increasing worldwide, placing considerable demand on public health systems and driving a necessity to develop more effective targeted therapies.

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Infosys and Top Pharma Bring Digital Transformation to DrugManufacturing Data

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In 2017, a top 20 global pharmaceutical company began a journey to digitally transform its pharmaceutical engineering and manufacturing capabilities by constructing a data integration and visualization platform, with strategic assistance and technical implementation provided by its partner Infosys.

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NEXTGEN PHARMA TAKES ‘SMART’ STRIDES WITH INTERNET OF THINGS

whitePaper | December 20, 2022

Digitization of processes and data across the value chain along with the emergence of Internet of Things (IoT) has transformed the Pharma industry.

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Coronavirus (COVID-19) and Its Effect on Pharmaceutical Marketing and Sales

whitePaper | March 16, 2020

With the rapid onset of coronavirus in the United States, many pharma companies are being forced to prepare for a scenario in which their reps cannot visit providers and patients are limited in their ability to visit their healthcare professionals (HCP). The CDC has gone as far as recommending the use of telemedicine and patient portals as primary channels for HCPs and patients to interact.

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Market Access Trends in the US, Europe, and Emerging Markets

whitePaper | November 14, 2022

Rising drug spending and increased desire for expenditure controls are consistent themes across the US, Europe, and emerging markets.

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Spotlight

Asia Pharmaceutical Industries

ASIA Pharmaceutical Industries is one of the pioneering pharmaceutical companies in Syria and the Middle East. Within two decades, a dedicated and highly qualified team of scientists and healthcare professionals has developed a world-class company that has been awarded international quality certificates: cGMPs, ISO 9001, ISO 14001 as well as the OHSAS 18001.

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