Wednesday, November 13, 2019
Webinar: The 21st Century Cures Act and Real World Evidence: What the Trial Lawyer Needs to Know
12:00 PM - 01:00 PM
Please join us for a complimentary Webinar (Web-based seminar produced through Adobe Connect) sponsored by the IADC Drug, Device and Biotechnology Committee, Medical Defense and Health Law Committee, and Product Liability Committee on Wednesday, November 13, 2019 for (1) hour beginning at: 10:00 AM PST / 11:00 AM MST / 12:00 PM Noon CST / 1:00 PM EST.
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The 21st Century Cures Act and Real World Evidence: What the Trial Lawyer Needs to Know
The 21st Century Cures Act (Cures Act) was designed to accelerate the discovery, development, and delivery of new medical products. One key feature of the Cures Act is that patients’ perspectives are to be further incorporated in the FDA’s decision-making process. The Cures Act also includes a framework for evaluating the use of real world evidence and data to support the FDA’s regulatory decisions. The Cures Act was widely supported by the pharmaceutical and medical device industry and could bring great benefit to patients and to the advancement of medical products. At the same time, the acceleration in approval of medical products, the use of patients’ perspectives in the approval process, and the use of non-clinical trial data in regulatory decision-making will bring some of plaintiffs’ favorite trial themes to the forefront. Join us for a discussion on what this might mean for trial strategy and how to effectively address these themes at trial.
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For details on any upcoming Webinar, please visit the Webinar page on the IADC website.
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