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Real-World Evidence Conference

Translating Insights into Real-World Value.


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

Marni Hall, PhD, MPH

  • Vice President, Clinical Evidence
  • IQVIA, United States
Delphine  Saragoussi, MD, MSc

Delphine Saragoussi, MD, MSc

  • Executive Director, Real-World Evidence
  • Evidera, 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)

Richard  Forshee, PhD

Speaker

Richard Forshee, PhD

  • Associate Director for Analytics and Benefit-Risk Assessment, CBER
  • FDA, United States
Alison  Cave, PhD

Speaker

Alison Cave, PhD

  • Chief Safety Officer
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Patrice  Verpillat, DrMed, MD, PhD, MPH

Speaker

Patrice Verpillat, DrMed, MD, PhD, MPH

  • Head of Global Epidemiology
  • Merck Healthcare KGaA, Germany
Rohini  Hernandez, PhD, MPH

Speaker

Rohini Hernandez, PhD, MPH

  • Director of Observational Research
  • Amgen, Inc., United States