Exploring the Rise of RWE in Regulatory Submissions
Tuesday, September 24, 2019 | 1:00pm - 2:00pm EDT

In December 2018, the FDA released a new strategic framework to advance the use of real-world evidence (RWE) to support development of drugs and biologics. The framework serves as a roadmap for more fully incorporating real-world data (RWD) and RWE, with the ultimate goal of developing a clear path to ensure RWE solutions are part of drug development and regulatory life cycles. How does this framework impact biopharma manufacturers’ current and future drug development plans? How does it change current RWE approaches for generating data on safety and effectiveness? What does this mean for the future of clinical trials?

Join Cardinal Health experts on Tuesday, September 24th at 1:00 PM EST as we analyze case studies and discuss best practices for incorporating RWE as part of the regulatory process.

Speakers:

Bruce Feinberg, DO
Vice President of Clinical Affairs & Chief Medical Officer
Cardinal Health Specialty Solutions

Todd Phillips, PharmD, RAC
Director of Global Regulatory Affairs, Regulatory Sciences Group
Cardinal Health Specialty Solutions

Eli Phillips, Jr., PharmD, JD
Vice President for Insights & Engagement and Regulatory Sciences
Cardinal Health Specialty Solutions

Jonathan Kish, PhD, MPH
Director & Team Lead of the Real-World Evidence & Insights Division
Cardinal Health Specialty Solutions

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