Back to Agenda
Session 3: How Does the Growing Use of RWE to Support Regulatory Decision-Making Impact Generation of Post-Marketing RWE?
Session Chair(s)
Marni Hall, PhD, MPH
VP & GM, Global Regulatory Science and Strategy
IQVIA, United States
Delphine Saragoussi, MD, MSc
Executive Director, Real-World Evidence
PPD, part of Thermo Fisher Scientific, France
The focus of RWE generation in the regulatory space has recently expanded from the post-marketing phase to the pre-marketing phase with increasing focus on generating RWE to support regulatory decision-making. This has been driven first by the need to optimize data generation in rare diseases and precision medicine, has been boosted by the COVID-19 pandemic and an unprecedented wave of emergency use authorizations; it is also used as a way to ensure more diversity in clinical research.
By putting RWE under the spotlight and by creating a continuum of RWE between the pre- and post-marketing space, this recent development is expected to impact the way post-marketing RWE is generated, e.g. in terms of scope, methods and data quality
Experts from the pharmaceutical industry will share their experience and perspective on these changes globally and how they impact the way they generate post-marketing RWE on a daily basis and will have the opportunity to exchange with a regulator. In particular, they will focus on the early planning of post-marketing RWE, the choice of data sources, and data quality requirements. They will also share practical learnings on engaging with regulators on RWE.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss the most current trends for the use of real- world evidence and data
- Describe some scenarios where post-marketing RWE generation is influenced by current trends in the pre-marketing space
- Identify opportunities and challenges of RWE generation in the regulatory context
Speaker(s)
Speaker
Richard Forshee, PhD
FDA, United States
Deputy Director, OBPV CBER
Speaker
Alison Cave, PhD
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Safety Officer
Speaker
Patrice Verpillat, DrMed, MD, PhD, MPH
European Medicines Agency, Netherlands
Head of Real World Evidence
Speaker
Rohini Hernandez, PhD, MPH
Amgen, United States
Director, Center for Observational Research
Have an account?