On-demand archive: http://media01.commpartners.com/ISPE/Boston2015/Sun/207PM/index.html

Elizabeth Andrews FISPE, VP Pharmacoepidemiology and Risk Management, RTI Health Solutions
Course introduction and objectives
Overview of Risk Management and the Role of Evaluation

Priya Bahri, Pharmacovigilance Lead for Guidelines and Risk Communication, European Medicines Agency
EU GVP requirements and examples – the thread of risk management, communication and evaluation

Gerald Dal Pan, Director, Office of Surveillance and Epidemiology,
Center for Drug Evaluation and Research, US Food and Drug Administration
Requirements and Lessons Learned from Evaluating REMS in the US – Update from FDA

Carla Van Bennekom, Epidemiologist, Slone Epidemiology Center, Boston University
Examples and Evaluations

Judith Jones, FISPE, President and CEO, The Degge Group, Ltd.
Workshop for Participants to Develop an Evaluation Program for a Risk Minimization Plan