MR Ba... C... ... WESTFIELD, NJ 07090 Us
In the following industries:
Pharmaceuticals, devices, biotech, IT
Fields of practice:
Drug Safety & Pharmacovigilance, Quality & Compliance, Regulatory
Management teams your interventions may concern:
Types of interventions:
Head of global drug safety in industry; as a consultant: Organizational change & reengineering, SOP creation and rewriting; inspections & audits, risk management, drug safety white papers, regulatory intelligence, planning & strategy;crisis management; short or long term
Training courses attended:
-MD, New York University School of Medicine (NYU)
-Residency & Board Certification: Internal Medicine (NYU)
-Fellowship & Board Certification: Gastroenterology (NYU)
-Resident etranger-hepatologie-Hopital Beaujon/INSERM Paris
Led training courses:
All areas of drug safety. I have done and led courses around the US, Canada, China and elsewhere in English and French
electronic data capture, safety database design, integration, upgrades, work flow management, MedDRA, dictionaries
Provided upon request
Presentation sheet cretaed / updated on: 2009-04-07 21:43:05
US board certified in Internal Medicine and Gastroenterology. He graduated from the New York University School of Medicine with an MD and trained there in Medicine and Gastroenterology. He did a subsequent Hepatology post-doc at the Hôpital Beaujon/INSERM (Clichy, France). He was in practice at NYU-Bellevue Hospital before joining the pharmaceutical industry. He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Physicians. He is licensed in 3 states and on the staff at the NYU School of Medicine and UMDNJ.
He has worked at Ives Laboratories (now Wyeth), Hoechst-Roussel Pharmaceuticals (now Sanofi-Aventis), Schering-Plough, Novartis Consumer Health, Forest Laboratories and Becton Dickinson. He was head of global drug safety at Schering Plough from 1993 until his retirement in 2004. He also headed the global drug safety group at Novartis Consumer Health and has a decade of experience in clinical research (running phase II, III, IV studies).
From 1989 to 2004 he served on various International Conference on Harmonisation (ICH) working groups, co-chairing one, representing PhRMA covering GCP, E2B and PSURs. He is on the Editorial Board of the journal Expert Opinion in Drug Safety.
He has written three textbooks (two with a coauthor) on Drug Safety including the Manual of Drug Safety and Pharmacovigilance published by Jones & Bartlett in 2007. It is used as the textbook in various drug safety courses. He is a series editor for medical textbooks at Jones & Bartlett and is currently at work on three additional books. He has multiple publications in refereed journals.
He has been an invited speaker at many courses and conferences including DIA, the European Society of Pharmacovigilance, the WHO Anniversary Symposium on Pharmacovigilance, PERI, the University of Montréal, Tufts University, Brigham & Women's Hospital, Temple University, the Journées Annuelles de Santé Publique (Quebec), Chinese Food & Drug Administration (SFDA) Training Session in Clinical Research (Sanya, China) and elsewhere.
He has experience in drug safety software development both at Schering Plough and at Medidata Solutions Inc.
In addition to over 18 years in drug safety and pharmacovigilance, He has senior level experience in drug safety crisis management, interactions with FDA & other health authorities, organizational re-engineering, training, compliance/quality, GCP, risk management and drug safety software development.
He is a dual US & French citizen.