About the Keynote Speaker

David GoldsmithDavid Goldsmith, MD
President, Senior Consultant
Goldsmith Pharmacovigilance and Systems

David I. Goldsmith, MD FISPE is currently the President and Senior Consultant of Goldsmith Pharmacovigilance and Systems, has previously served as Vice-President for Safety Surveillance at Sanofi-Synthelabo, and now does part-time consulting. In particular he participates as a member or chairperson for several DSMB’s, develops plans and SOPs for safety operations, conducts audits of them (including the evaluation of software tools), and provides recommendations for Benefit-Risk Activities including the development of both REMs and RiskMAPs.  

ICH and PhRMA: Dr. Goldsmith has played an active role in PhRMA (Pharmaceutical Research and Manufacture Association). He is a past Chair of the Clinical Safety Surveillance Committee (CSSC), and was 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: Points to consider. He was a participant in the International Conference on Harmonization and served on the US and International E2 Expert Working Groups, and was the Rapporteur for the ICHE2BM project, He was also an active participant and a frequent industry spokesperson for the FDA MedWatch program. He served as an industry consultant to the FDA AERs project which developed the FDA database, and was a participant in the AERs and Eprompt working.

ISPE: Since joining the pharmaceutical industry Dr. Goldsmith has been an active participant in Pharmacoepidemiology. He served as a board member, Vice President and Vice President of Finance for ISPE (International Society of Pharmacoepidemiology) and he was the Scientific Program Chair for three of the International Conferences. He was presented with the Society’s Distinguished Service Award, and he has been granted Fellow status

DIA and Teaching Experience: Dr. Goldsmith was the Co-chair for the DIA Clinical Safety and Pharmacovigilance SIAC and a member of the ACNA and has been an invited speaker for numerous DIA meetings, with particular reference to the regulations concerning safety monitoring and the application of Data Mining techniques. He has also been invited to speak at professional conferences sponsored by the for profit organizations offering courses on safety surveillance. He has served as the Course Co-Director for the PERI Course on Adverse Event Monitoring.

Academic Orientation: After fulfilling his military obligation at the National Naval Medical Center in Bethesda, MD, he conducted bench and clinical research at Albert Einstein College of Medicine where he served as an Associate Professor of Pediatrics. During his tenure at Albert Einstein, he authored and co-authored more than 50 publications and was the Director of the Coordinating Center for the International Study of Kidney Disease in Children. He 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.
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