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J.-P. Clement MD

J.-P. Clement MD

Executive Pharmacovigilance Consulting

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About the author:

Dr. Clement is an Executive Pharmacovigilance Consultant for the pharmaceutical industry. He has worked over the last 26 years in Drug Safety and Pharmacovigilance in multiple capacities, mostly with global PV responsibilities at the VP level. He has worked for companies such as Janssen, Merck KgA, Abbott, Sanofi, Onyx and Cubist His consulting practice focuses on helping Pharmaceutical Companies to design and implement highly efficient and compliant PV structures and processes, with high strategic output. Dr. Clement graduated in Family Medicine from Pierre and Marie Curie Medical University, Paris, France, and worked in clinical practice for 8 years before joining the pharmaceutical industry. He also studied Pharmacology at Pierre & Marie Curie Paris 6, Lariboisiere Paris 5 and Claude Bernard Lyon Universities, France.


Posts by J.-P. Clement MD

The Liabilities of Pharmacovigilance Activities

Posted on June 21st, 2017 in Pharmacovigilance

There is always a risk that any Pharmacovigilance (PV) activity, even executed with the highest business and ethical standards, and with the highest compliance results, could be challenged, sometimes many years later. As a member of a PV team, you may have to one day justify your actions in front of a group of plaintiff’s lawyers, Continue reading “The Liabilities of Pharmacovigilance Activities” »

Protocol Deviations and Serious Breach Expedited Reporting

Posted on May 19th, 2017 in Pharmacovigilance

Protocol deviations will occur even with the best designed clinical trial protocols and investigator training. Although minimizing such protocol breaches is an absolute mandate for Clinical Trial Sponsors, there are specific deviations (usually qualified as “major”) which require expedited reporting if they impact patient safety. Continue reading “Protocol Deviations and Serious Breach Expedited Reporting” »

The Four Cornerstones of a Pharmacovigilance Organization

Posted on May 8th, 2017 in Pharmacovigilance

For small organizations, building a PV department from the ground up can be an exercise of trial and error, frustrating and costly. Being in growth mode means that there is not much time to anticipate and plan, as multiple high priorities compete for attention. Continue reading “The Four Cornerstones of a Pharmacovigilance Organization” »

How to Establish a Solid PV Training Curriculum?

Posted on April 5th, 2017 in Pharmacovigilance

There are many elements to consider when you develop a training curriculum for your PV team. A training curriculum defines which roles (rather than individuals) in a group should be trained on which processes. Here are some elements to consider if you want to maximize your training efforts in order to be efficient, compliant and inspection-ready. Continue reading “How to Establish a Solid PV Training Curriculum?” »

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