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From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
Session Chair(s)
William Blumentals, PhD
Head of Pharmacoepidemiology, Specialty Care
Sanofi, United States
This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.
Learning Objective : Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.
Speaker(s)
Panelist
Susan A. Oliveria, DrSc, MPH
Thermo Fisher Scientific, United States
Vice President, Global Head of Epidemiology and Scientific Affairs Peri- and Pos
Panelist
Jie Li, PhD
FDA, United States
Associate Director for RWE, OSE, CDER
Panelist
Alice Hsu, MPH
Amgen Inc., United States
TA Safety
Panelist
James Buchanan, PharmD
Covilance LLC, United States
President
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