戻る Agenda
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
Speaker(s)
Elements of an Effective and Efficient Review Process from an Agency Point of View
Dato' Eisah A. Rahman
Ministry of Health Malaysia, Malaysia
Senior Director of Pharmaceutical Services
How Does Industry See the Review Process Evolving to Address the Needs of Tomorrow?
Paul D. Huckle
GlaxoSmithKline, United States
Chief Regulatory Officer and Senior Vice President, Global Regulatory Affairs
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
Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor and Consultant
Results of APEC Good Review Practices (GRP) Project
Chao-Yi Wang, MSC
TFDA, Taiwan
Senior Researcher