返回 Agenda
Breaking Down the Wall for Global Regulators to Leverage Real World Data
Session Chair(s)
Duane Schulthess, MBA
Chief Executive Officer
Vital Transformation LLC, United States
This forum will present global perspectives on the use of real world evidence for drug and device regulatory decision making including postmarket surveillance, fast track or acceleration programs, conditional approval programs.
Learning Objective : Describe a global view of access and use of data.
Speaker(s)
Lessons Learned From the EMA Adaptive Pathways Pilot Project: The Need for a Real-World Data Strategy for Success
Radek Wasiak, PHD, MA
Cytel, Singapore
Chief Data Officer and Head of Europe
When and How Can Health Care Database Analyses Replace RCTs in Marketed Medications?
Sebastian Schneeweiss, DRSC, MD
Harvard Medical School and Brigham and Women's Hospital, United States
Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology
Panelist
Alison Cave, PHD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Panelist
Nicola Bedlington
European Patient's Forum, Belgium
Special Advisor