With the new Communications with Payors and Consistent with Labeling draft guidance documents, as well as the proliferation of big data, real world evidence has become increasingly prominent—relied upon by payors and potentially by health care professionals and other stakeholders. However, real world evidence is not classical randomized controlled clinical trial data. How should we evaluate real world evidence? What are the potential permitted uses of real world evidence? How strong should the data be before using it in a promotional context or as the basis for a value based contract? What guidelines should apply to manufacturer promotional communications of real world evidence? This webinar will explore the use of real world evidence and provide a framework through which to view the appropriate use of the evidence.
Joy J. Liu, VP, Commercial and Regulatory Legal, Vertex Pharmaceuticals, Inc., and Secretary and General Counsel, FDLI Board of Directors
Meredith Manning, Partner, Hogan Lovells US LLP
Kirke Weaver, Vice President, Office of General Counsel, Merck & Co., Inc.
Moderated by Michael Labson, Partner, Covington & Burling LLP