About the Author

Dr. Michael J. Klepper is an independent consultant who specializes in pharmacovigilance and drug safety.He graduated from Loyola University Stritch School of Medicine, was elected to Alpha Omega Alpha (National Medical Honor Society) and received board certification in Internal Medicine and Emergency Medicine. As President and CEO of Integrated Safety Systems, Inc. (ISS) and as Vice President of Safety and Pharmacovigilance at Research Triangle Institute – Health Solutions (RTI-HS), Dr. Klepper provided comprehensive pharmacovigilance-related services to numerous pharmaceutical and biotech clients.His 25 years of industry experience also includes preparation of the Integrated Summary of Safety, Summary of Clinical Safety, Periodic Safety Update Reports, and other safety reports; medical product safety training; and global drug development. Of particular importance to Dr. Klepper is comprehensive medical review and ongoing benefit-risk determination for pre- and postmarketed medical products.He also has a keen interest in the evaluation and application of new technological tools and their uses for enhancing risk assessment.Dr. Klepper frequently lectures as a drug safety expert and is president of Michael J. Klepper, MD, LLC based in Research Triangle Park, North Carolina. Barton Lewis Cobert MD, FACP, FACG, FFPM has had a long career in the clinical practice of Gastroenterology and Internal Medicine as well as, in the pharmaceutical industry specializing in drug safety and risk management. For over a decade he was Global Head of Drug Safety (side effects) for the Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. He has also worked in the information technology industry at Medidata Solutions. Dr. Cobert was born in New York City and received his BA from New York University and his MD from New York University School of Medicine. He is board certified in Internal Medicine and Gastroenterology. He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Medicine (UK). He has written and lectured extensively both nationally and internationally on drug safety, side effects and the safe use of medications. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety. Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company in Westfield, NJ.