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Session 8: Now What? What Type of Evidence Will be Needed for Registering Biosimilars in the Future?
Session Chair(s)
Mauricio Ede, MD, PhD
Chief Medical & Scientific Officer
Sandoz Canada Inc., Canada
Cecil J. Nick, MS
FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom
Following updated guidelines from MHRA and the upcoming guidelines from WHO, Health Canada, and other regulatory agencies, join us to learn more about perspectives and tendencies on data requirements for registration of biosimilars. You will learn where “the puck will be” from regulators, industry and patient groups representatives and healthcare professionals.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify the tendencies and different perspectives on the evolution of data requirements for licensing of biosimilars from regulators, HCPs, industry, and patients association representatives
- Assess the applicability of insights to the US Marketplace
- Devise plans for implementation while leveraging perspectives from markets similar to the US
Speaker(s)
Speaker
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Speaker
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Speakers
Martin Schiestl, PhD
Sandoz GmbH, Austria
Global Head Regulatory Affairs Policy
Speaker
David Murray, PhD
Parexel International Ireland Ltd., Ireland
Principal Consultant
Speaker
Peter Joseph Kiely, MD
Parexel, Ireland
Vice President, Technical