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Session 8: Asia Regional Update on Convergence
Session Chair(s)
Jerry Stewart, JD, MSC, RPH
Vice President Global Regulatory Policy and Intelligence, Global RA
Pfizer Inc, United States
Chao-Yi Wang, MSC
Senior Researcher
TFDA, Taiwan
This session will present both industry’s and the regulatory authorities’ views on the status of regulatory convergence in Asia. Examples of Regulatory convergence and divergence will be discussed, including recommendations on how to progress more convergence in areas such as clinical development, submission standards, risk-benefit assessments and approval time lines. Highlights from APEC RHSC, PhRMA and other organizations will help to paint a picture of the current regulatory environment and emerging topics on harmonization for attendees to consider.
Speaker(s)
Overview of Regulatory Convergence in Asia
Gloria Hung, RPH
Pfizer, Inc., Hong Kong
Head of Regulatory Affairs North Asia Cluster (Pakistan, Taiwan, Hong Kong)
Recent Convergence Efforts
Justina Molzon, JD, MS
Consumer Services, United States
Consumer Services
Industry's Role in APEC RHSC
Shun-Wen Chang, PHD
Bristol Myers Squibb, China
Vice President, North Asian Regulatory Strategy an
TFDA's View on Regulatory Harmonization and Its Efforts to Implement It
Chao-Yi Wang, MSC
TFDA, Taiwan
Senior Researcher