Keynote Presentation - From Drug Safety to Risk Management: Where Have We Been and Where Are We Going?
Presented by Dr. David Goldsmith, Goldsmith Pharmacovigilance and Systems
FDA Updates Session
Featuring Dr. Gerald J. Dal Pan, Office of Surveillance and Epidemiology, CDER, FDA and Dr. Ellis Unger, Office of Drug Evaluation-I, OND, CDER, FDA
New EU Regulations Session
Featuring Dr. Stella C.F. Blackburn, European Medicines Agency
Panel Debate: Will We Ever Move Towards More Quantitative Benefit-risk Analysis?
Featuring debate speakers from FDA, PDMA, Eli Lilly and Company, Janssen R&D and Purdue Pharma L.P.
International Regulatory Updates Session
Featuring Adalton G. Ribeiro, Brazil Health Surveillance Centre and Dr. Marc Berthiaume, Health Canada
Social Media Panel Discussion
Featuring Dr. Linda J. Scarazzini, Division of Pharmacovigilance I, CDER, FDA