Scheduled Date
August 26-28, 2026
Venue Location
Taipei, Chinese Taipei
| Day 1 – Aug. 26, 2026 (Wed.) | ||||
|---|---|---|---|---|
| Time | Topic | Speaker | Room | |
| 08:40 – 09:10 | Registration | 1001 | ||
| Opening Remarks | 1001 | |||
| 09:10 – 09:25 | Opening Remarks |
Chih-Kang Chiang Director-General, Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei MD/GRM PWA Co-Champion: Ayumi Endo Office Director, Office of Asia Training Center and International Cooperation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan GRM PWA Co-Organizer: Masaaki Kanno Leader, Regulations and Approvals Expert Working Group (RA-EWG), APAC, and SP Team Lead, Overseas Regulatory Office, Regulatory Affairs Department, Otsuka Pharmaceutical Co., Ltd., Japan |
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| 09:25 – 09:35 | Group Photo | |||
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PWA Introduction & Special Topic |
1001 | |||
| 09:35 – 09:50 | Roadmap and Core Curriculum of GRM/MD PWA |
MD PWA: Kazuyoshi Takatori Special Appointed Staff, OAIC, PMDA, Japan GRM PWA: Ayumi Endo Office Director, OAIC, PMDA, Japan |
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| 09:50 – 10:40 |
Special Keynote: Combination Products
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Huai-Yao Chuang Reviewer, Division of Medical Devices, Center for Drug Evaluation (CDE), Chinese Taipei Andreas Emmendoerffer Principal Regulatory Program Director, Pharma Technical Regulatory – Devices and Combination products, Roche Pharma Ltd, Switzerland |
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| 10:40 – 11:00 | Break (GRM move to Room 801) | |||
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Session 1: Core Competencies of Drug Applicants and Reviewers |
801 | |||
| 11:00 – 11:40 | Define the core competency of applicants & reviewers |
Lawrence Liberti Director, The D. K. Kim International Center for Regulatory Science, University of Southern California (USC) |
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| 11:40 – 12:00 | Q & A | |||
| 12:00 – 13:30 | Lunch | |||
| Session 2: Managing and conducting the review | 801 | |||
| 13:30 – 14:00 | TFDA's Strategies for Regulatory Resilience and Efficient Regulation of APIs and Generic Drugs (TBD) |
Chi Chung Section chief, Division of Medicinal, TFDA |
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| 14:00 – 14:30 | Drugs Regulatory Strategies and Review Mechanisms for Generic Drugs: Insights from PMDA (TBD) |
Mayu Nozawa Reviewer, Office of Generic Drugs, PMDA |
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| 14:30 – 15:00 | Drugs Regulatory Strategies and Review Mechanisms for Generic Drugs: Insights from TGA |
Brian Dooley (Virtual) Pharmaceutical Quality Senior Specialist, European Medicines Agency (EMA) |
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| 15:00 – 15:20 | Panel discussion |
【Moderator】 Mei-Chen Huang Senior Technical Specialist, Division of Medicinal Product, TFDA 【Panelists】 Chi Chung Section Chief, Division of Medicinal Product, TFDA Hiroshi Takeda PMDA Mayu Nozawa Reviewer, Office of Generic Drugs, PMDA Brian Dooley (Virtual) Pharmaceutical Quality Senior Specialist, EMA |
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| 15:20 – 15:40 | Break | |||
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Session 3: Updates on Drug Review Mechanisms Across Economies |
801 | |||
| 15:40 – 15:50 | Representative of Chile |
Cristina Troncoso CMC Reviewer, Biological Register Department, Public Health Institute of Chile (ISP) |
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| 15:50 – 16:00 | Representative of India |
Harish Gautam Drugs Inspector, Central Drugs Standard Control Organisation (CDSCO) |
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| 16:00 – 16:10 | Representative of Malaysia |
Thanu Radha Maiyauen Senior Principal Assistant Director, Generic Medicines Section, Centre of Product & Cosmetic Evaluation, National Regulatory Pharmacy Agency (NPRA) |
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| 16:10 – 16:20 | Representative of Peru |
Erik Adrian Cotera Yactayo Pharmaceutical Chemist (Q.F.), General Directorate of Medicines, Supplies and Drugs (DIGEMID) |
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| 16:20 – 16:30 | Representative of Philippines |
Michael Galang Food-Drug Regulation Officer IV, Center for Drug Regulation and Research, FDA Philippines |
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| 16:30 – 16:40 | Representative of Thailand |
Piyaporn Chootikul Pharmacist Professional, Pharmaceutical Substance Promotion Subdivision, Medicine Regulation Division, Thai FDA |
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| 16:40 – 17:00 | Q&A | Representatives from each economy | ||
| 17:00 – 17:10 | Day 1 Questionnaire | |||
| 17:10 – 18:00 | Break (move to Welcome Reception, B1F) | |||
| 18:00 – 20:00 | Welcome Reception | B1 | ||
*Day 1, Opening, PWA Introduction, Special Keynote will be open to the public.
| Day 2 – Aug. 27, 2026 (Thu.) | |||||
|---|---|---|---|---|---|
| Time | Topic | Speaker | Room | ||
| 08:30 – 09:00 | Registration | 803 | |||
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Session 4: Planning of Application |
803 | ||||
| 09:00 – 10:00 |
Lectures
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【Moderator】 Wen-Chi Yang (Tammie) Regulatory Affairs Associate Director, Eli Lilly and Company (Taiwan) 【Speaker】 Finny Liu APAC Regional Regulatory Policy Lead, Roche Singapore Jocelyn Lee Regulatory Affairs Head, Alinamin Pharmaceutical Taiwan Ltd. 【Facilitator】 TFDA/CDE/IRPMA |
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| 10:00 – 10:10 | Break | ||||
| 10:10 – 11:00 | Group Discussion | ||||
| 11:00 – 11:55 | Group Presentation | ||||
| 11:55 – 12:00 | Take Home Message | ||||
| 12:00 – 13:00 | Lunch | ||||
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Session 5: Preparation of Application Dossier |
803 | ||||
| 13:00 – 13:50 |
Lectures
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【Moderator】 Hiroko Kawaguchi Sr. Director, Regulatory Affairs Area Reg Strat & Liaison, Japan Development, MSD.K.K. 【Speaker】 Toru Suzuki Head, Reg & Dev Policy, Regulatory Affairs Japan, Development Division, Novartis Pharma K.K. Kohei Koyama Regulatory Affairs Dept., Chugai Pharmaceutical Co., Ltd. 【Facilitator】 TFDA/CDE/IRPMA |
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| 13:50 – 14:00 | Break | ||||
| 14:00 – 15:00 | Group Discussion | ||||
| 15:00 – 15:55 | Group Presentation | ||||
| 15:55 – 16:00 | Take Home Message | ||||
| 16:00 – 16:10 | Break | ||||
| Session 6: Communications |
803 | ||||
| 16:10 – 17:00 |
Lectures
|
【Moderator】 Min Chen Former Acting Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, CDER, US FDA 【Speaker】 Min Chen Former Acting Director of Division of Pharmacovigilance, Office of Surveillance and Epidemiology, CDER, US FDA Jessica Tsai Sr. Regulatory Affairs Director, Asia North Cluster & Taiwan, Merck Sharp & Dohme (I.A.) LLC, Taiwan Branch 【Facilitator】 TFDA/CDE/IRPMA |
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| 17:00 – 17:30 | Group Discussion | ||||
| 17:30 – 18:00 | Group Presentation | ||||
| 18:00 – 18:05 | Take Home Message | ||||
| 18:05 – 18:10 | Day 2 Questionnaire | ||||
| Day 3 – Aug. 28, 2026 (Fri.) | |||
|---|---|---|---|
| Time | Topic | Speaker | Room |
| 08:30 – 09:00 | Registration | 801 | |
| Session 7: Critical Thinking and Regulatory Decision-making | 801 | ||
| 09:00 – 09:30 | TFDA Intelligent Review for Pharmaceutical Regulatory Assessment (TBD) |
Po-Wen Yang Senior Technical Specialist, Division of Medicinal, TFDA |
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| 09:30 – 10:00 | Current Trends in AI for Regulatory Review and Decision-Making: Insights from PMDA |
Sakurana Fukud Coordinator, Review Planning Division, Office of Review Management, PMDA |
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| 10:00 – 10:30 | Current Trends in AI for Regulatory Review and Decision-Making: Insights from EMA |
David Filipovic(Virtual) Digital Portfolio Lead, EMA Paul Zabbal(Virtual) Innovation Manager, EMA |
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| 10:30 – 10:40 | Q & A | All Speakers | |
| 10:40 – 10:45 | Day 3 Questionnaire | ||
| 10:45 – 11:00 | Break (move to Room 1001) | ||
| Closing Remarks | 1001 | ||
| 11:00 – 11:50 | Certificate Award Ceremony |
Chih-Kang Chiang Director-General, TFDA, MOHW, Chinese Taipei |
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| 11:50 – 12:00 | Closing Remarks / Group Photo | ||
