Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.Related Link(s)

Dr Barton Cobert MD, FACP, FACG is an expert on Drug Safety and medication side effects, and author of several textbooks and multiple journal articles on these topics. He has extensive experience in Drug Safety, Clinical Drug Research, Regulatory Affairs, Risk Management, and Computer Informatics in pharmaceuticals. He was previously in practice doing gastroenterology before entering the pharmaceutical world as Global Head of Drug Safety at Schering Plough and Novartis OTC. Dr Cobert is a graduate of the New York University School of Medicine where he also did his training in Internal Medicine and Gastroenterology. He also did a post-doctoral fellowship in liver disease in France. He is board certified in Internal Medicine and Gastroenterology. He is on staff at NYU and at Rutgers University where he is an Adjunct Associate Professor. Dr Cobert is now President of the consulting group BLCMD Associates LLC in Chapel Hill, NC which is actively engaged in drug safety, risk management and PV crisis resolution.Dr William W Gregory received formal training in infectious diseases and molecular mechanisms of pathogenesis. He is an international expert in pharmacovigilance, clinical safety data evaluation, electronic safety data exchange, and healthcare informatics. His background includes work in Level 4 bio-containment units, identification and susceptibility testing of infectious agents, and more than 15 years of experience directing successful global biopharmaceutical product development and registration programs. He was a pathology professor at the University of Virginia Medical Center and served as a consultant to the US Veteran's Administration. Dr Gregory also has extensive teaching experience, including programs with PhD candidates, house staff, and medical and pharmacy students from Weill Cornell, New York University, Rutgers University, the Philadelphia College of Pharmacy, the University of Connecticut, and the University of Hertfordshire, among others. He is the author or co-author of more than 50 peer-reviewed scientific articles or abstracts. He has also developed continuing education programs and delivered lectures for several professional societies, including the Drug Information Association. Dr Gregory has served with other experts and senior scientists on many international consensus panels, including the International Council for Harmonization, the Council for International Organizations of Medical Sciences, the International Organisation for Standardisation, and Health Level 7. He is currently responsible for pharmacovigilance strategy and policy at Pfizer on a worldwide basis.Dr Jean-Loup Thomas MD started his medical carrier at the Paris Poison Control and Pharmacovigilance Center. He then moved to the pharmaceutical industry within Pharmacovigilance for several companies, at both affiliate and corporate levels. He is an expert in Clinical Pharmacology, Clinical Safety / Pharmacovigilance, Safety Signals and Risk Management, Drug Safety Crisis, Data Monitoring Committees / Data Safety Monitoring Boards, Labelling / Product Information and Clinical Development. He has been EU QPPV within the Sanofi group and also led the Sanofi Global Labelling team. He is now Senior Consultant for the clinical pharmaco-toxicology department at the Hospices Civils de Lyon (France).