戻る Agenda
Breakout Session 1 A: Global CMC Reviews: Challenges and Opportunities
Session Chair(s)
Lucky Surjadi Slamet, MSC
Deputy,Therapeutic Prod, Narcotics, Psychotropic and Addictive Substance Control
NADFC, The Republic of Indonesia, Indonesia
Chi-Wan Chen, PHD
Pfizer, Inc., United States
Speaker(s)
CMC Review: Challenges and Opportunities - Singapore HSA Perspective
Dinesh Khokal, PHD, MSC
Health Sciences Authority, Singapore
Regulatory Consultant, Generics & Biosimilars Branch
Changes in CMC Submission and Review
Zhen Chen, PHD
Center for Drug Evaluation of CFDA , China
Deputy Office Director, Office of New Drug Pharmaceutical Science
Challenges to Multi-National Companies in a Global Regulatory Environment – with Case Studies
Chi-Wan Chen, PHD
Pfizer, Inc., United States