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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

Can We Apply Leadership Skills to Writing Pharmacovigilance SOPs?

Posted on August 18th, 2017 in Pharmacovigilance

The Policies, Procedures and other Quality Documents that we use as a backbone to our daily PV activities are the fundamental references for ensuring the consistency of the execution of our activities. They also ensure adequate documentation Continue reading “Can We Apply Leadership Skills to Writing Pharmacovigilance SOPs?” »

The Importance of the Safety Management Plan for Clinical Trials

Posted on June 30th, 2017 in Pharmacovigilance

In a world where many operational and strategic clinical trial activities are outsourced to Contract Research Organizations (CROs), the design and content of the Safety Management Plan (SMP) will greatly influence the execution of clinical trial drug safety activities. Continue reading “The Importance of the Safety Management Plan for Clinical Trials” »

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” »

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