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Renaissance Washington DC Dupont Circle Hotel

Oct 27, 2016 8:15 AM - Oct 28, 2016 5:00 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Biosimilars 2016

Preview the New Agenda for DIA Biosimilars 2016, the Premier Global Biosimilars Conference.

Session 4: The Role of Real-World Evidence (RWE) in the Post-Approval Setting

Session Chair(s)

Thomas  Felix, MD

Thomas Felix, MD

Medical Director, R&D Policy, Global Regulatory Affairs and Safety

Amgen Inc., United States

This session will explore the role of RWE in the post-approval setting for biosimilars. RWE can be used for a range of purposes that span product safety to commercial interests. The presentations and panel discussion will focus on the current state of RWE to inform pharmacovigilance, extrapolated indications, comparative effectiveness, product utilization, and value assessments. You will also assess the utility of the FDA’s Sentinel Initiative as a source for biologic and biosimilar studies. Other National regulatory authorities are empowered to conduct real-world analyses when similar national databases are developed and available for public health purposes.

Speaker(s)

Nancy A Dreyer, PhD, MPH, FISPE

Key Questions Stakeholders Ask About Biosimilars Post-Approval

Nancy A Dreyer, PhD, MPH, FISPE

Dreyer Strategies LLC, United States

Founder

Brian  Bradbury, DrSc, MA

Key Challenges to Addressing Post-Approval Biosimilar Questions

Brian Bradbury, DrSc, MA

Amgen, United States

Vice President, Center for Observational Research

Alan  Brookhart

Methodologies for Addressing CER/CSR: Strengths and Limitations

Alan Brookhart

University of North Carolina, Chapel Hill, United States

Professor, Department of Epidemiology, Gillings School of Global Public Health

Panel  Discussion

Panel Discussion

All Session Speakers, United States

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