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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. Our research showed that in Europe between 1999 and 2016, 35 products were withdrawn. But over time, trends in what evidence is most available and therefore most used, change.

Medicine 111
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How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

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Industry Briefs May 2023

PM360

In addition, IBM will be preparing Moderna’s scientists to use its technology, with the company participating in the IBM Quantum Accelerator program and the IBM Quantum Network through which access to IBM’s quantum computing systems can assist Moderna in exploring life sciences use cases powered by quantum technologies.

Safety 52
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The Traditional Pharma Model Isn’t Working – It’s Time to Evolve!

PharmaKinnex

The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. More convenience and safety? Fewer Networking & Industry Trade Show Events. Hiring, training, and managing sales representatives were never cheap. August 23, 2022. dstansberry@costellocreativegroup.com.

Pharma 52
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Why patient-centricity is essential to accelerate rare disease clinical research

European Pharmaceutical Review

5,6 Clinical trials are essential for the safety and efficacy of novel therapies to be established. In fact, one-quarter of rare disease trials between 2016 and 2020 were terminated due to low accrual rates.

Patients 117