#281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU
Tuesday, June 18, 2024 4:30 PM to 5:30 PM · 1 hr. (US/Pacific)
Room 6B
03: Data-Tech
Information
A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Regulator PerspectivesReal-World Data (RWD)- Real-World Evidence (RWE)
Speakers

Steffen Thirstrup
Chief Medical OfficerEuropean Medicines Agency
Motiur Rahman
Senior Epidemiologist and Policy Advisor, Real World Evidence Analytics, OMP, CDFDA
Sabine Haubenreisser
Principal Scientific Administrator, Stakeholders and Communication DivisionEuropean Medicines Agency
Dave deBronkart
Patient AdvocateE-Patient Dave, LLCBB
Brian Bradbury
Vice President, Center for Observational ResearchAmgenLP
Laura Pizzi
Chief Science OfficerISPOR
