David I. Goldsmith, MD FISPE is recognized internationally for his work in Drug Safety and Pharmacoepidemiology. He was previously Vice President, Safety Surveillance at Sanofi~Synthelabo, Inc. He is a founding member of the International Society of Pharmacoepidemiology and served as a board member, Vice President, Vice President of Finance, and was the program chair for 3 of the International Conferences. He was honored by receiving the ISPE Distinguished Service Award, and was elected to the status of Fellow. He has played an active role in PhRMA and was Chairperson of the Clinical Safety Surveillance Committee, and a member of the Clinical Steering Committee.  He served as the PhRMA representative to the initial MedDRA working party and he worked on the MedDRA Good term Selection. He was a participant in the International Conference on Harmonization and served on the US and International ICH E2B Expert Working Groups, and was the Rapporteur for the ICHE2BM project. He has been an active participant and a frequent industry spokesperson for the implementation of FDA’s MedWatch program, and served as an industry consultant to the FDA AERs project. He was a participant in the AERs and Eprompt working groups for piloting electronic safety data submissions to the FDA.  He was the Co-chairperson for the Drug Information Association’s Clinical Safety and Pharmacovigilance SIAC and a member of the ACNA. He has served as the Course Co-Director for the PERI Course on Adverse Event Monitoring. Dr Goldsmith is a frequent invited speaker at conferences in the US and Europe including DIA, PERI, and numerous other safety surveillance conferences, with particular reference to regulations concerning safety monitoring and Data Mining techniques.

Dr Goldsmith is a graduate of the New York Medical College and is board certified in Pediatric Nephrology. He conducted bench and clinical research at Albert Einstein College of Medicine where he served as an Associate Professor of Pediatrics.  He authored and co-authored more than 50 publications, was the Director of the Coordinating Center for the International Study of Kidney Disease in Children, served on the College’s Institutional Review Board, and chaired the section on adverse event evaluation.  He also served as the Chairman of the Subcommittee on Microprocessors of the Committee on Scientific Services.