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Session 1b Focus on Post-Approval Changes
Session Chair(s)
Sannie S Foong Chong, PhD
Senior Director, Global Regulatory Policy
MSD International, Singapore
Helene Sou, MSc, RAC
Global Regulatory Policy and Innovation
Takeda Pharmaceutical Company Limited., Singapore
Speaker(s)
Ignite the Future - Our Exciting PAC Reliance Journey with 48 NRAs
Suat Gnoh Por
Roche Singapore Technical Operations Pte Ltd, Singapore
Regulatory Program Director
ASEAN Country Specific Requirements for Post-Approval Changes: Current Challenges and What Can Be Streamlined / Harmonized to Achieve More Efficiency in Regulatory Processes for PACs
Sia Lee Yoong
GSK, Singapore
Regulatory Policy Executive
“Recent and Ongoing Improvements and Streamlining of Regulatory Processes for PACs –FDA Philippine Experience”
MA. THERESA. PIA C. YAP
FDA Philippines, Philippines
Food-Drug Regulations Officer II – IV, LRD, CDRR
Thai FDA : MA and Post Approval Changes Update
Marakot Papassiripan
Thai FDA, Thailand
Pharmacist, Professional level Biological product sub-div Bureau of Drug Control
Jeffrey Schnack
Accumulus Synergy, Japan
Japan Project Lead
Mei-Ling Chan
Taiwan Food and Drug Administration, Taiwan
Reviewer
Paul Huleatt, PhD
Therapeutic Goods Administration (TGA), Singapore
Indo-Pacific Regulatory Strengthening Program Intl Regulatory Branch
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