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Session 5: Positive Regulatory Decisions Enabled by Real -World Evidence
Session Chair(s)
David Martin, MD, MPH
Vice President, Head, PCO Center of Excellence, Novartis, United States
Brian Bradbury, DRSC, MA
Vice President, Center for Observational Research, Amgen, United States
The ability to generate RWE that can enable a regulatory decision is no small feat. As we have learned during the discussions at this and in previous conferences, through direct engagement with regulators and from insights gleaned in the literature, “regulatory-grade” RWE is a very high standard. In this session we will take a deeper dive into a number of successful use cases where manufactures have generated decision-enabling RWE that has led to a positive regulatory decision (i.e., regulatory grade RWE).
Learning Objective : - Recognize the regulatory & clinical development context that made an RWE-enabled development strategy attractive
- Highlight the selection of data & methods that were fit-for-purpose & the early interactions that promoted regulatory alignment
- Review various information requests received as regulatory agencies pressure tested key findings
- Understand the nature of the approval/authorization decision & the basis for considering RWE fit-for-purpose
Speaker(s)
Rob Kalesnik-Orszulak, PHARMD
Head of Regulatory Affairs, Retro Biosciences, United States
Speakers
Tzu-Chieh (Jay) Lin, PHD, MPHARM
Observational Research Director, Amgen, United States
Speaker
Nicole Kellier-Steele, PHD, MPH
Senior Director - Global Patient Safety, Eli Lilly and Company, United States
Speaker
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