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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

Compliance Metrics for Pharmacovigilance Activities

Posted on August 19th, 2016 in Pharmacovigilance

Measuring the compliance of a defined set of variables is key for functions like pharmacovigilance, where there is intense reporting to different regulatory and non-regulatory entities with strict regulations and high inspection risk. (more…)

The Changing Competencies of Pharmacovigilance Leadership

Posted on June 27th, 2016 in Pharmacovigilance

Significant transformations happened over the last decade regarding the role of pharmacovigilance (PV) departments in pharmaceutical organizations. This had a tremendous impact not only on the technical knowledge needed, but more importantly on the non-technical competencies that should be required for any PV role in pharma. (more…)

Did you just say Safety Governance Model?

Posted on May 27th, 2016 in Pharmacovigilance

We usually tend to think that our overall compliance to regulations and fulfilling our ethical commitment to patient safety is best answered through an established set of Policies and SOPs. We design processes around regulatory mandates and adjust to the complexity of the enterprise as much as we can, feeling confident that all our bases are covered. (more…)

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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