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| Sidney N. Kahn, President, PvRM |
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| Dr. Sidney Kahn is CEO of Pharmacovigilance & Risk Management Inc., a consulting company he established in 2002. Sidney has been at the forefront of US and international developments in pharmacovigilance, risk assessment, and risk management for the past decade. He holds a medical degree from the University of Cape Town, a Ph.D. from the University of London, and specialist certification in Chemical Pathology (Clinical Biochemistry) by the Royal College of Pathologists, London. He is a member of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, U.K. After 17 years in academic laboratory medicine directing large hospital laboratories and conducting basic research in neuroimmunology in the UK and USA, he joined the pharmaceutical industry in 1990 and began working on safety assessment of medicinal products throughout their life cycle.
In addition to his quotidian pharmacovigilance responsibilities, he participated actively in US and international pharmacovigilance groups, including:
· chairing the Terminology Subcommittee of the PhRMA Committee on Clinical Safety
· representing PhRMA on the ICH M1 Expert Working Group on Medical Terminology, which developed MedDRA®
· representing PhRMA on the MedDRA® MSSO evaluation panel
· representing PhRMA on the MedDRA® Term Selection Points To Consider working group
· representing PhRMA on the ICH V1 EWG established in February 2002
· representing PhRMA on the National Coordinating Council for Medication Error Reporting and Prevention
· membership of the Leadership Team of the PhRMA Safety, Epidemiology & Post-Marketing Surveillance Technical Group (formerly Committee on Clinical Safety).
He is currently a member of the CIOMS VI working group on clinical trial safety assessment and DIA SIACs for Terminology Management, Clinical Safety and Pharmacovigilance, and Labeling.
In his last pharmaceutical industry position, he managed a large group of physicians and scientists responsible for the safety assessment of investigational and marketed products and personally developed innovative approaches to signal detection and evaluation and risk management plans for developmental and newly marketed products.
He has given many presentations on various aspects of pharmacovigilance, including:
· implementation and application of MedDRA®, including both medical and regulatory perspectives
· optimization of safety labeling
· implications for pharmaceutical companies of evolving regulatory and other international developments in pharmacovigilance and risk management.
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