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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 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. (more…)

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. (more…)

Building PV SOPs: Where to start?

Posted on March 17th, 2017 in Pharmacovigilance

Having a set of operating standards defined through Quality Documents (QDs) is the only route to compliance and performance. QDs are defined as documents such as Policies, SOPs, Work Instructions (WINs), Manuals, Charters and Memo to File. (more…)

PV Audit by Quality: Friends or Foes?

Posted on March 9th, 2017 in Pharmacovigilance

One of the major ways to measure the health of a Pharmacovigilance (PV) organization is to organize regular audits by experienced Quality Assurance (QA) auditors. During such audits, how open should PV be with the auditors (more…)

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