Real World Evidence Innovation Regulatory Science

《 21世纪治疗法》，COVID-19和计划于2021年下半年进行的现实世界数据指南，使人们对现实世界数据（RWD）和现实世界证据（RWE）的力量的关注点更加明显。在新数据，方法和工具方面，RWE在提供监管科学和创新的价值方面仍然处于最前沿。您如何以适合用途的方式利用RWE来支持监管提交？

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，医学博士，博士，MPH
Senior Director, U.S. Regulatory Science and Strategy