Real World Evidence, Innovation, and Regulatory Science – What you should know to keep up in the rapidly evolving regulatory landscape

Webcast

Thursday, August 19, 2021 at 2pm EDT RWE continues to be at the forefront in providing value in regulatory science and innovation when it comes to new data, methods, and tools. In this webinar, learn how RWE can be leveraged in a manner that is fit-for-purpose, to support a regulatory submission.

Register Free: http://www.pharmexec.com/pe_w/innovation

Event overview:

The 21st Century Cures Act, COVID-19, and the pending real world data guidance slated for later in 2021, have brightened the spotlight on the power of real world data (RWD) and real world evidence (RWE). RWE continues to be at the forefront in providing value in regulatory science and innovation when it comes to new data, methods, and tools. How do you leverage RWE in a manner that is fit-for-purpose, to support a regulatory submission?

During this webinar, hear from IQVIA leader Dr. Marni Hall, former Director, Regulatory Science Office of Surveillance and Epidemiology at the FDA, and current Vice President for Clinical Evidence and Head of U.S. Regulatory Science and Strategy at IQVIA, on the use of RWE for regulatory decision-making.

IQVIA speaker, Dr. Marni Hall will discuss the importance of regulatory science as regulators innovate, and the critical role the industry plays in helping to shape the future use of RWE. The presentation will introduce RWD and RWE, discuss innovative approaches and processes you can take back to your organization to foster use of RWE, and highlight success stories in leveraging RWE to support regulatory approvals. You don’t always know how useful your data can be, the insights you can glean, and the opportunity it presents, until that data is looked at through another lens.

3 key takeaways

  1. Understand what RWE is and how it may be used in regulatory decision-making.
  2. Better understand what fit-for-purpose data and studies entail, and why one-size fits all approaches do not apply when it comes to using RWE for regulatory decision making.
  3. Learn how innovation is part of the regulatory process and how you can bring this information and innovative ways of thinking back to your organization.

Speakers

Marni Hall, PhD, MPH
VP Clinical Evidence, Head of U.S. Regulatory Science and Strategy
IQVIA

Register Free: http://www.pharmexec.com/pe_w/innovation