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Using Real World Evidence for Regulatory Support: Time to Embrace the Future
Session Chair(s)
Nancy A Dreyer, PhD, MPH, FISPE
Founder
Dreyer Strategies LLC, United States
As mandated under the 21st Century Cures Act, in December 2018, the FDA is scheduled to issue a draft framework and guidance for evaluating real world evidence (RWE) to help support the approval of a new indication for an already approved drug, and to help support or satisfy post approval study requirements. This session will examine the latest FDA thinking and global experience in terms of decision support for label expansions and other regulatory decisions.
Learning Objective : Describe the latest FDA thinking about the use of real world evidence (RWE) for regulatory decision making as a supplement to or in lieu of traditional RCT; Apply this knowledge to product development to generate the RWE most likely to be used by regulators; Recognize how to get better ROI from RWE by understanding the differential roles of clinical and surrogate outcomes.
Speaker(s)
Lessons from Approval of a Drug to Treat Metastatic Merkel Cell Carcinoma
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products
FDA Perspective
Tamy Kim, PharmD
FDA, United States
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence
Rethinking the Process for Post-Market Requirements
Andrew Robertson, JD, PhD
Takeda, United States
Vice President, Head of Global Regulatory Policy and Innovation
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