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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

Practical aspects of the “new” IND Rule

Posted on May 23rd, 2016 in Pharmacovigilance

The FDA IND reporting rule[i], mandatory since March 2011, has had a major impact on the sponsor’s responsibilities to report safety information representing a potential change in the risk profile for products that are under investigation. (more…)

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