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Renaissance Washington DC Downtown Hotel

Jan 26, 2015 8:30 AM - Jan 28, 2015 4:00 PM

999 Ninth Street NW, Washington, DC 20001

Pharmacovigilance and Risk Management Strategies 2015

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Session 9 - Enhancing Pharmacovigilance Engagement in the Clinical Development of Large Molecules

Session Chair(s)

Stephen Knowles, MD, MRCP

Stephen Knowles, MD, MRCP

Chief Medical Officer

Halozyme Therapeutics, United States

The Clinical Relevance of Quality

Speaker(s)

Steven Kozlowski, MD

The Clinical Relevance of Quality

Steven Kozlowski, MD

FDA, United States

Director, Office of Biotechnology Products, OPQ, CDER

Jan Hillson, MD

Establishing Biosimilarity through Assessment and Comparison of Critical Quality Attributes

Jan Hillson, MD

Momenta Pharmaceuticals, Inc., United States

Senior Director of Clinical and Research

Thomas Felix, MD

Pharmacovigilance: Considerations for Biologics and Biosimilars

Thomas Felix, MD

Amgen Inc., United States

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

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