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Session 7: DILIGENT ASSESSMENT OF BIOSIMILARS ENSURING PATIENT SAFETY
Session Chair(s)
Keith Watson, PhD
Director, Global Regulatory Affairs, Biologics Strategic Development, AbbVie Ltd, United Kingdom
Ensure timely accessibility of high quality efficacy & safety profile biosimilar to patients of the Middle East region. Building capabilities at Health Authorities end & faster access to patients.
Speaker(s)
WHO Experience
Ivana Knezevic
Technical Standards and Specifications Unit (TSS), World Health Organization, Switzerland
EU Regulator Assessments
Sean Barry, PhD
Senior Pharmaceutical Assessor , Health Products Regulatory Authority (HPRA), Ireland
Biosimilars Regulation in the Region – A Case Study
Ali M. Al Homaidan
Executive Director, Product Evaluation Executive Directorate, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Biosimilars Regulation in the Region – A Case Study
Mona Saleh
Director of Biological Registration Directorate, Ministry of Health, Egypt
Biosimilars Regulation in the Region – A Case Study
Ramy Behbehani, MS
Drug Registration and Release Superintendent, Kuwait Drug & Food Control Adminstration Kuwait, Kuwait
IFPMA Perspective
Fabio Bisordi, MSc
Global Head International Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
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