Real-World Evidence Conference

Session Chair(s)

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)