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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
World Health Organization, Switzerland
Technical Standards and Specifications Unit (TSS)
EU Regulator Assessments
Sean Barry, PhD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
Biosimilars Regulation in the Region – A Case Study
Ali M. Al Homaidan
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Executive Director, Product Evaluation Executive Directorate
Biosimilars Regulation in the Region – A Case Study
Mona Saleh
Ministry of Health, Egypt
Director of Biological Registration Directorate
Biosimilars Regulation in the Region – A Case Study
Ramy Behbehani, MS
Kuwait Drug & Food Control Adminstration Kuwait, Kuwait
Drug Registration and Release Superintendent
IFPMA Perspective
Fabio Bisordi, MSc
F. Hoffmann-La Roche Ltd, Switzerland
Global Head International Regulatory Policy
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