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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)
Gloria Hung, RPH
Head of Regulatory Affairs North Asia Cluster (Pakistan, Taiwan, Hong Kong) , Pfizer, Inc., Hong Kong
Overview of Regulatory Convergence in Asia
Justina Molzon, JD, MS
Consumer Services, Consumer Services, United States
Recent Convergence Efforts
Shun-Wen Chang, PHD
Vice President, North Asian Regulatory Strategy an, Bristol Myers Squibb, China
Industry's Role in APEC RHSC
Chao-Yi Wang, MSC
Senior Researcher, TFDA, Taiwan
TFDA's View on Regulatory Harmonization and Its Efforts to Implement It
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