Let’s Get Real: The Growing Importance of RWD and RWE in Regulatory Decision-Making
Thursday, September 22, 2022 | 10am EST / 5am PST / 4pm CET | 60 min
Nach Dave, R.Ph., M.S., Vice President Development Strategy, Premier Research
Abie Ekangaki, Vice President, Statistical Consulting. Premier Research
Angela Drew, Ph.D., Director Regulatory Strategy, Premier Consulting
Real-world data (RWD) and real-world evidence (RWE) play a growing role in regulatory decision-making on new drug and biologic products. The US Food and Drug Administration’s (FDA) recent release of new guidance on use of this information is prompting sponsors, payers, physicians and others to recognize the value of RWD and RWE. They complement and supplement traditional clinical research methods, prompting the industry to use them more effectively.
In this webinar, development and regulatory experts from Premier Research and Premier Consulting will be discussing aspects of FDA’s RWE Guidance. This refers to the data-sharing provisions within the 21st Century Cures Act and the exploding use of mobile devices, wearables and other biosensors for gathering and storing health-related data and its impact on RWD/RWE.
Just what constitutes “real-world” information, and what qualifies as a reliable real-world data source? How does usage of this intelligence differ between small biotechs and large pharma companies, and how can they leverage this information successfully?
Join this webinar to address the many facets of real-world evidence and real-world data in regulatory decision-making.
In this webinar, attendees will:
- Learn the distinct purposes and meanings behind real-world data (RWD) and real-world evidence (RWE)
- Learn how to leverage RWD and RWE information in regulatory decisions for an effective impact on clinical trial study design
- Find out what constitutes reliable sources for RWD, given the large (and growing) body of electronic medical records and other types of medical information
- Look at strategies for establishing the extent of RWD and RWE for supplementing, or even taking the place of, conventional clinical trials
- Explore an RWE success story — a case study in the successful use of RWE in obtaining regulatory approval