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 |
Speaker (TBD) Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei MD/GRM PWA Co-Champion: Speaker (TBD) Pharmaceuticals and Medical Devices Agency (PMDA), Japan GRM PWA Co-Organizer: Speaker (TBD) APAC Leader |
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| 09:25 – 09:35 | Group Photo | |||
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PWA Introduction & Special Topic 【Moderator】 TFDA |
1001 | |||
| 09:35 – 09:50 | Roadmap and Core Curriculum of GRM/MD PWA |
MD PWA: Speaker (TBD) PMDA, Japan GRM PWA: Speaker (TBD) PMDA or TFDA |
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| 09:50 – 10:40 |
Special Topic: Combination Products
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TFDA/CDE, Chinese Taipei (TBD) Industry (TBD) |
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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 【Moderator】 TFDA |
801 | |||
| 11:00 – 11:40 | Define the core competency of applicants & reviewers | Speaker (TBD) | ||
| 11:40 – 12:00 | Q & A | |||
| 12:00 – 13:30 | Lunch | |||
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Session 2: Managing and conducting the review Drugs Regulatory Strategies and Review Mechanisms for Generic Drugs 【Moderator】 TFDA |
801 | |||
| 13:30 – 14:00 | Insights from TFDA | TFDA (TBD) | ||
| 14:00 – 14:30 | Insights from PMDA | PMDA (TBD) | ||
| 14:30 – 15:00 | Insights from TGA | TGA (TBD) | ||
| 15:00 – 15:30 | Insights from EMA | EMA (TBD) | ||
| 15:30 – 15:50 | Panel discussion | All Speakers | ||
| 15:50 – 16:10 | Break | |||
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Session 3: Updates on Drug Review Mechanisms Across Economies 【Moderator】 TFDA |
801 | |||
| 16:10 – 16:20 | Representative of Economy #1 | Speaker (TBD) | ||
| 16:20 – 16:30 | Representative of Economy #2 | Speaker (TBD) | ||
| 16:30 – 16:40 | Representative of Economy #3 | Speaker (TBD) | ||
| 16:40 – 16:50 | Representative of Economy #4 | Speaker (TBD) | ||
| 16:50 – 17:00 | Representative of Economy #5 | Speaker (TBD) | ||
| 17:00 – 17:10 | Representative of Economy #6 | Speaker (TBD) | ||
| 17:10 – 17:20 | Q&A | Representatives from each economy | ||
| 17:20 – 17:30 | Day 1 Questionnaire | |||
| 17:30 – 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 【Moderator】 IRPMA |
803 | ||||
| 09:00 – 10:00 |
Lectures
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【Speaker】 IRPMA 【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 【Moderator】 APAC |
803 | ||||
| 13:00 – 14:00 |
Lectures
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【Speaker】 APAC 【Facilitator】 TFDA/CDE/IRPMA |
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| 14:00 – 14:10 | Break | ||||
| 14:10 – 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 | Lecture |
【Speaker】 Min Chen APAC 【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 |
| 08:40 – 09:00 | Registration | 801 | |
|
Session 7: Critical Thinking and Regulatory Decision-making Current Trends in AI for Regulatory Review and Decision-Making: Insights from TFDA, PMDA, and US FDA (or EMA) 【Moderator】 TFDA |
801 | ||
| 09:00 – 09:30 | Perspectives from TFDA | TFDA (TBD) | |
| 09:30 – 10:00 | Perspectives from PMDA | PMDA (TBD) | |
| 10:00 – 10:30 | Perspectives from US FDA (or EMA) | US FDA (or EMA) (TBD) | |
| 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 | Speaker (TBD) TFDA, MOHW, Chinese Taipei | |
| 11:50 – 12:00 | Closing Remarks / Group Photo | ||