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Riyadh Marriott Hotel

Nov 17, 2015 8:00 AM - Nov 18, 2015 5:15 PM

King Saud Road, Riyadh 11464, Saudi Arabia

11th Middle East Regulatory Conference (MERC) 2015

SESSION 3: REGULATORY INNOVATION AND CHALLENGES

Session Chair(s)

Trevor M. Jones, CBE

Trevor M. Jones, CBE

former Director General ABPI, King's College London, United Kingdom

The objective of this session is to share new paradigms in regulatory science and current developments. To facilitate registration of medicinal products & increase efficiency (through collaboration, work-sharing and implementation of global norms and standards).

Speaker(s)

Lembit  Rago, DrMed, MD, PHD

Lembit Rago, DrMed, MD, PHD

Secretary General, Council for International Organizations of Medical Sciences (CIOMS), Switzerland

WHO Perspective

Florence  Roizard, PHARMD

Florence Roizard, PHARMD

Vice President, Regulatory Affairs International, MSD France, France

Industry Perspective

Hajed M.H Hashan

Hajed M.H Hashan

Deputy of General Director, Gulf Health Council, Saudi Arabia

The Saudi Food and Drug Authority: An Evaluation of Registration Procedures & Good Review Practices in Saudi Arabia in Comparison with Australia, Canada & Singapore

Stuart Russel Walker, PHD

Stuart Russel Walker, PHD

Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom

A Structured Approach to the Benefit-Risk Assessment of Medicines: Key to Improving Decision Making in Drug Development and the Regulatory Review in the Gulf Region

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