Risk Management in the US, EU and Japan: The Challenges of Diversity
Track
:
Track 14: Clinical Safety and Pharmacovigilance
Program Code:
281
Date:
Tuesday, June 25, 2013
Time:
4:00 PM to 5:30 PM
EST
Location:
153AB
CHAIR
:
Nancy A. Dreyer, PhD,MPH,FISPE (SCHNON), Senior Vice President, Global Chief of Scientific Affairs, Quintiles Outcome, United States
Nancy A. Dreyer is Global Chief of Scientific Affairs and Sr Vice President at Quintiles Outcome. Dreyer specializes in the conduct of observational research on comparative effectiveness and safety of medicines and medical devices, and is active in methods development.
SPEAKER
(S):
Gerald J. Dal Pan, MD (SPKAGY), Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins. He trained in Internal Medicine at the Hospital of the Univ of Pennsylvania, and in Neurology at Johns Hopkins. He is board certified in Internal Medicine and Neurology.
Stella C.F. Blackburn, MD,MA,MSc,FFPM,FISPE,FRCP (SCHAGY), EMA Risk Management Development and Scientific Lead, European Medicines Agency, European Union, United Kingdom
Currently risk mgt development and scientific lead at EMA, Dr Blackburn has worked in hospital medicine, in the pharmaceutical industry, and was a Specialised Group Leader at EMA. She originally co-developed the course in PhV and PhEPi at LSHTM where she is Hon. Lect. She is President Elect of ISPE
Stewart Geary, MD (SCHNON), Vice President, Chief Medical Officer, Director, Corporate Medical Affairs HQ, Eisai Co., Ltd., Japan
Stewart Geary has worked at Eisai since 1996 in PV, clinical safety and regulatory science. He is a member of the CIOMS IX Working Group, the Executive Committees of JAPhMed and the CEPM and the Editorial Advisory Boards for Applied Clinical Trials, IFAPP World and Pharmaceutical Medicine.
Description
Two regulators and a global safety officer will discuss differences in legislation and the challenges of risk management planning in the US, EU and Japan. Questions from the audience will be facilitated by a moderator.