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The mission of the Evidence Generation Focus Area Working Group (FAWG) is to educate the MAPS membership on contemporary practices for data generation strategies, including the design, implementation, and communication of new evidence, and educate the MAPs membership how real-world (RW) evidence may be utilized to support product value; including labeling changes.
To reach our goals, the Evidence Generation FAWG will execute on two key objectives. First, through educational programs and communications, we will increase understanding of requirements for Evidence Generation in the context of Medical Affairs strategic planning & execution of evidence generation plans. Second, we will explore applications of real-world evidence across stakeholders within Medical Affairs, with the purpose of increasing the acceptance of real-world evidence for regulatory purposes.
As part of this plan, we will organize a host of Evidence Generation activities including workshops for MAPS meetings in the North America, with longer term plans and aspirations of conducting Evidence Generation workshops in APAC (Asia Pacific – China/Japan), and EMEA (Europe, Middle East, Asia) regions.
We will develop original content for webinars, podcasts, eLearning courses, and white papers. In addition, the working group will periodically contribute cogent and timely content on the Evidence Generation sector for the MAPS publication, Elevate magazine. Most importantly, we will provide a supportive resource for all Medical Affairs professionals seeking advice and direction on data generation and regulatory strategies.
Description: MAPS speaks with Kent Summers, HEOR Lead at AlphaGroup and Steve Camper, VP of Medical Affairs at Blue Earth Diagnostics, about building Health Economics and Outcomes Research capabilities within Medical Affairs.
Head of HEOR Medical Strategy, Immunology
President, C James LLC
Life Sciences Attorney
VP, Medical Affairs International Developed Markets
Executive Director, Medical Communications & Operations
Associate VP, Value, Evidence, & Outcomes for Neuroscience
Senior Director, Global Medical Affairs Office Integrated Evidence Generation
General Manager, Medical Affairs
Senior Director, Head of HEOR International Markets and Greater China,
Astellas Pharma Global Development
Director, HEOR Oncology, Medical Affairs US
Global Head, RWE
Partner & Clinical Director
Global Medical Strategy and Value Lead
International Medical Affairs Franchise Lead
VP, Medical Affairs
People and Product Leader in Product Development Data Sciences