Back to Agenda
Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU
Session Chair(s)
Steffen Thirstrup, MD, PHD
Chief Medical Officer, European Medicines Agency, Netherlands
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.
Learning Objective : Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.
Speaker(s)
EMA Update
Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Industry Update
Chief Science Officer, ISPOR, United States
Patient Update
Patient Advocate, E-Patient Dave, LLC, United States
Industry Update
Vice President, Center for Observational Research, Amgen, United States
FDA Update
Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Have an account?