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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

Crisis Prevention in Pharmacovigilance

Posted on October 12th, 2016 in Pharmacovigilance

One of the challenging situations that Pharmacovigilance functions will have to manage one day or another is a pharmacovigilance crisis. (more…)

The New Clinical Trial Directive, Low Risk Intervention Clinical Trials and Pharmacovigilance Reporting Adjustments

Posted on October 3rd, 2016 in Pharmacovigilance

The new Clinical Trial Directive (EU 536/2014), is applicable since May 2016 with a transition period of three years (May 2019) for CT applications submitted before that date. (more…)

The Expanding Role of PV in Pre-marketing Activities

Posted on September 7th, 2016 in Pharmacovigilance

There is an inherent challenge in bringing Pharmacovigilance expertise into the development phase of medicinal products for the first time, especially for small pharmaceutical companies. (more…)

What do Pharmacovigilance and Market Research Programs have in common?

Posted on September 2nd, 2016 in Pharmacovigilance

If you want an example of why PV needs to be very closely involved in Patient Support Programs (PSP) or Market Research Programs (MRP), what happened recently to a very large pharmaceutical company should be a wake-up call for checking where you are on this topic. (more…)

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