Making sense of FDA's 2021 real-world evidence guidance
Watch as Aetion’s scientific and regulatory leaders explored FDA's evolving approach to RWE and tools you can use to generate regulatory-grade evidence.
Speakers
Nicolle Gatto, PhD, MPH
Chief Science Officer, Aetion
Nirosha Mahendraratnam Lederer, PhD, MSPH
Director, RWE Strategy, Aetion
Jeremy Rassen, ScD, MS
Co-Founder and President, Aetion
Lowell Schiller, JD
Chief Legal and Regulatory Officer, Aetion
Objectives
Clarify FDA’s RWE strategy
Discuss high-level implications of recent draft guidances, including required actions
Describe draft guidance alignment with existing scientific methodologies and tools
