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SESSION 11: Biosimilars
Session Chair(s)
Ali AlSamil
Head of Biotech and Biosimilar Products Department
Saudi Food and Drug Authority (SFDA), Saudi Arabia
SESSION 10: Biosimilars
Speaker(s)
Introduction & Setting the Scene – Evolution and Global Efforts (IPRP and ICH)
Ali AlSamil
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Head of Biotech and Biosimilar Products Department
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Sarah Yim, MD
FDA, United States
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Mohammed H. Aldosari, PhD
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Director of Biological Products Directorete
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Anne Cook
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Quality Assessor (Biologicals) Healthcare, Quality and Access group
Global Perspectives - Evolution of the Regulatory Framework for Biosimilars, Experiences and Lessons Learned
Andrea Laslop, MD
Malta Medicines Authority, University of Innsbruck, Austria
Former Head of Scientific Office, AGES & Regulatory expert, lecturer
Industry Perspective
Virginia Acha, PhD, MSc
Merck Sharpe & Dohme LLC , United States
AVP, Global Regulatory Policy
Panel Discussion with Q&A (With the additional participation of):
Panellist(s) Invited
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