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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
Senior Regulatory Program Director, Roche Singapore Technical Operations Pte Ltd, Singapore
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
Regulatory Policy Executive, GSK, Singapore
“Recent and Ongoing Improvements and Streamlining of Regulatory Processes for PACs –FDA Philippine Experience”
MA. THERESA. PIA C. YAP
Food-Drug Regulations Officer II – IV, LRD, CDRR, FDA Philippines, Philippines
Thai FDA : MA and Post Approval Changes Update
Marakot Papassiripan
Pharmacist, Professional level Biological product sub-div Bureau of Drug Control, Thai FDA, Thailand
Jeffrey Schnack
Japan Project Lead, Accumulus Synergy, Japan
Mei-Ling Chan, PhD
Reviewer, Taiwan Food and Drug Administration, Taiwan
Paul Huleatt, PhD
Indo-Pacific Regulatory Strengthening Program Intl Regulatory Branch, Therapeutic Goods Administration (TGA), Singapore
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