Introduction to Pharmacovigilance

Speaker: Gregory Fiore, MD, Head of North America Pharmacovigilance, Schering-Plough

Pharmacovigilance (PV) is a term used to describe activities related to adverse reactions for drug products. This presentation will introduce the basic ideas of PV and will provide a background into the development of the system in the United States and administered by the US Food and Drug Administration. We will review examples of circumstances when the existing system has failed to maintain safety of the drug supply and talk about how requirements have evolved.

Gregory Fiore, MD was valedictorian of his class at New York Medical College and received several awards for both academic and clinical proficiency. He received residency training in Internal Medicine at Harvard Medical School's Brigham and Women's Hospital and is Board Certified. He also received clinical training in Pulmonary/Critical Care Medicine at the Harvard Program before joining McKinsey and Company as a consultant.

From McKinsey, Greg moved into the pharmaceutical industry at Abbott Laboratories where he first became exposed to the principles of PV. He then joined The Medicines Company where he played several roles including the Head of PV, Alliance Management, and Leader of a Phase II program.

Greg joined Schering Plough in 2007 and returned to PV as the head of North America PV.