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Sunday, June 20 • 12:00pm - 1:00pm
#541 OD: Asian Town Hall

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Component Type: Session
Level: Intermediate

“Regulatory convergence” has been advancing in Asia and expectation to this region as a field of drug development is also increasing. This session shares latest efforts for “regulatory convergence” in Asia and discuss future direction.

Learning Objectives

Describe activities to promote convergence in Asian country; Discuss activities based on convergence in Asian country; Discuss findings from FDA’s perspective.

Chair

Nobumasa Nakashima, PhD

Speaker

NMPA Perspective
Si Yuan Zhou

ASEAN Convergence in Pharmaceutical Inspections
Sia Chong Hock, MSc

FDA Perspective
Michelle Limoli, PharmD, RPh



Speakers
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory... Read More →
avatar for Sia Chong Hock

Sia Chong Hock

Senior Consultant, Audit and Licensing, Director Quality Assurance, Health Sciences Authority (HSA), Singapore
He is the Director of Quality Assurance and Senior Consultant at the Health Products Regulation Group of the Singapore Health Sciences Authority. Mr Sia is also an Adjunct Associate Professor with the National University of Singapore and immediate past Chair of the ASEAN Joint Sectoral... Read More →
avatar for Michelle Limoli

Michelle Limoli

Senior International Health Science Advisor, Office of the Director, CBER, FDA, United States
Michelle Limoli is the Senior International Health Science Advisor in FDA’s CBER. She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at... Read More →
SY

Si Yuan Zhou

Deputy Director of CDE, Head of ICH China Office, National Medical Products Adminsitration (NMPA), China
Mr. Zhou is the deputy director of the Center for Drug Evaluation (CDE), NMPA, China. He has been entitled in 2017 council member for Chinese Pharmaceutical Association and executive member for China Pharmacopoeia Commission. Mr. Zhou has 12-years’ clinical review experience, as... Read More →


Sunday June 20, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session