Honour and Keynote Speech
  • Dr. Chiang Yu-Mei
TFDA, Taiwan
  • Keynote Speaker 1
WHO, Switzerland - Invited
  • Keynote Speaker 2
US FDA, United States – Invited

Panel discussion  
  • Dr. Junko Sato
PMDA, Japan
  • Ms. Barbara Sabourin
Health Canada
  • Dr. Li-Lin Liu
TFDA, Taiwan

Session 1: Principles of Good Review Practice
  • Ms. Caroline Vanneste
Health Canada
  • Ms. Justina Molzon
Former US FDA, United States
  • Dr. Tomas Salmonson
EMA, Europe

Session 2: Co-operation, Convergence, Competencies & Capacity, and Communication in Managing the Review
  • Prof. John Lim
CoRE, Duke-NUS Graduate Medical School, Singapore
Examining 6 Cs of Good Regulatory Review Practices
  • Ms. Cordula Landgraf
Swissmedic, Switzerland
Evolving regulatory cooperation platform for the review of generics – IGDRP Initiative
  • Prof. Stuart Walker
CIRS, UK
Update on Southeast Asia Benefit Risk Evaluation (SABRE) Program

Hot Topics I: Achieving Earlier Patient Access to Medicines
Dr. Nobumasa Nakashima MHLW, Japan
Introduction to SAKIGAKE strategy
Mr. David Verbraska  Pfizer, United States  
Dr. Hans Georg Eichler EMA, Europe