Regulatory Intelligence Working Group Monthly Meeting
Time: 12 October 2021 12 Noon Eastern Time (US and Canada)
Hiding in Plain Sight - Finding RWE Precedent in Public Information
The use of real-world evidence (RWE) for regulatory decision-making is an area of growing interest and discussion among regulatory professionals who support early and late-stage biopharmaceutical product development. When creating RWE-related regulatory strategies with your product teams, it is often crucial to inform your strategy with the successful (and unsuccessful) examples of prior regulatory approvals based on RWE. Finding these examples, however, can be particularly challenging without a basic understanding of the free tools, techniques, and data sources available to you. In this session, we will walk through the steps of planning and conducting RWE precedent research using FDA.gov, Google, and other freely available resources.
The Presenter: Chris Whalley, Associate Director, Regulatory Policy &
Intelligence, Seagen Inc.
Chris Whalley brings 20 years of experience in biotechnology & healthcare operations and is currently Associate Director of Regulatory Policy & Intelligence at Seagen Inc., a biopharmaceutical company focused on oncology therapies. Prior to joining Seattle Genetics, Chris established & led the global healthcare & life sciences regulatory program at Amazon Web Services, and he previously built regulatory & quality programs at Fred Hutchinson Cancer Research Center, Amgen, and a number of pre-commercial biotech companies in the Seattle area. Chris also founded and sold a publishing company catering to life science organizations, and he holds a patent on supplying regulatory compliance evidence for cloud service provider environments. When not at work, Chris enjoys spending time with his family and tending to his fruit and vegetable garden.
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