Michael J. Klepper, M.D.

Dr. Klepper has over 23 years of pharmaceutical industry experience with particular expertise in medical product safety, risk assessment and pharmacovigilance. He was formerly President and CEO of Integrated Safety Systems, Inc. (ISS) a company he founded in 1996. ISS, which was acquired by Research Triangle Institute - International in 2006, provided a broad range of safety- and pharmacovigilance-related services including medical review, serious adverse event handling, review and preparation of many different safety documents (e.g., the annual safety report, the integrated summary of safety, the periodic safety update report, etc.), benefit-risk assessments, and strategic planning. Dr. Klepper is also an international trainer in these areas. He also has a keen interest in the evaluation and application of new technological tools as they relate to enhancing activities related to ongoing risk assessment. Dr. Klepper is currently a consultant in medical product safety, risk assessment and pharmacovigilance.