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Global Events

Raffles City Convention Centre

Jan 28, 2013 7:00 AM - Jan 30, 2013 5:00 PM

252 , North Bridge Road, Singapore 179103, Singapore

Asia Regulatory Conference 2013

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Session 5: Global Review Practives: Industry & Regulatory Working Together - Today and Tomorrow

Session Chair(s)

Cordula Landgraf, RPh

Head of Networking, Swissmedic, Switzerland

Steven K. Galson, MD

Senior Vice President, Global Regulatory Affairs and Safety, Amgen Inc., United States

“Coming Together is a Beginning, Keeping Together is Progress, Working Together is Success” (Henry Ford) In this sense, the session will look at how Industry and Regulatory already work together and what could be done by both sides in terms of effective and efficient review processes to further strengthen and improve this co-operation. Is the model of work sharing between Regulatory Agencies the way to enable effective resource utilization to finally streamline approval? And how could the review process evolve to balance early access to new drugs with the need for comprehensive data?

Speaker(s)

Elements of an Effective and Efficient Review Process from an Agency Point of View

Dato' Eisah A. Rahman

Senior Director of Pharmaceutical Services, Ministry of Health Malaysia, Malaysia

How Does Industry See the Review Process Evolving to Address the Needs of Tomorrow?

Paul D. Huckle

Chief Regulatory Officer and Senior Vice President, Global Regulatory Affairs, GlaxoSmithKline, United States

Is there an Internationally Acceptable Framework for Benefit-Risk Assessment of Medicines that will enable a Regulatory and Industry collaboration for improved decision making?

Stuart Russel Walker, PhD

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

Results of APEC Good Review Practices (GRP) Project

Chao-Yi Wang, MSc

Senior Researcher, TFDA, Taiwan

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