Back to Agenda
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)
Ivana Knezevic
Technical Standards and Specifications Unit (TSS), World Health Organization, Switzerland
WHO Experience
Sean Barry, PHD
Senior Pharmaceutical Assessor , Health Products Regulatory Authority (HPRA), Ireland
EU Regulator Assessments
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
Biosimilars Regulation in the Region – A Case Study
Fabio Bisordi, MSC
Global Head International Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
IFPMA Perspective
Have an account?