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?

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.

Speaker

Robbert Zusterzeel, MD, PhD, MPH
Senior Director, U.S. Regulatory Science and Strategy