2024 ISPE Singapore Affiliate Conference & Exhibition

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Open Tracks - Regulatory

Open Tracks

Open Tracks

1:40 pm

29 August 2024

Onsite Only @ Suntec Singapore - Room 1

Tracks

Regulatory Track

Session Programme

1:40 pm

Regulatory Track: Chair’s Opening Remarks

Alfonsus Karli, President & Regulatory Chair, ISPE Singapore Affiliate & Director, GCMC Vaccines, Pfizer, Singapore

1:45 pm

Regulatory Track: Regulatory Quality Harmonization Committee (RQHC) Asia Pacific Focus Group

Ryan Chan, Stephen Firmer, Yu Liang, Alfonsus Karli, Yuan Zhao

Alfonsus Karli, President & Regulatory Chair, ISPE Singapore Affiliate & Director, GCMC Vaccines, Pfizer, Singapore
Dr Stephen Firmer, Immediate Past President, ISPE Australasia & Director, Asia Pacific Consultants Pty Ltd, Australia

Ryan Chan, Head of Market Specific Requirements, Content Delivery, Global Regulatory Affairs, GSK, UK

Yu Liang, Associate Director, Regulatory CMC/Technical Advocacy & Policy APAC, MSD Singapore

Dr Yuan Zhao, CTO, Jiangsu Hillgene Biopharma Co Ltd, China

2:45 pm

Regulatory Track: GMP Compliance – Asia Pacific

Kentaro Hara, Vimal Sachdeva, Ellen, Ying-Hua Chen, Jennifer Burnett, Bob Tribe

Presenters:

Vimal Sachdeva, Senior GxP Inspector, WHO, Switzerland

Ellen Ying-Hua Chen, Deputy Director of Quality Compliance and Management, TFDA, Taiwan

Panel:
Moderator

Bob Tribe, ISPE Singapore Regulatory Affairs Advisor, Australia

Panelist
Jennifer Burnett, Assistant Secretary, Manufacturing Quality, TGA, Australia

Dr Kentaro Hara, Division Director, Division of Inspection for Drugs I, Office of Manufacturing Quality for Drugs, PMDA, Japan

4:30 pm

Regulatory Track: Drug Shortage Prevention: Where are We?

Jessica Hale, Global Regulatory Affairs & Clinical

Safety, Merck, USA

Other Suggested Tracks

Regulatory Track

29 August 2024 11:00 am

ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

Regulatory Roundtable

29 August 2024 11:45 am

ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1