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Workshop Agenda
Short Agenda Full Agenda
Time Day 1: 8/26 (Tue.) Day 2: 8/27 (Wed.) Day 3: 8/28 (Thu.)
Morning Registration
Opening Remarks
PWA Introduction
CoE Introduction 		Lecture #3: Review of Essential Principles of Medical Device Safety & Performance and Principles of Conformity Assessment

Group Practice:
MD Case Study
(1) Case Study Intro
(2) Group Discussion
(3) Group Presentation 		Lecture #5:
Clinical Evaluation
Lecture #1:
Current Harmonization Status of Pre-and Post-Market Regulation in Each Economy 		Expectations from the Workshop and Next Steps
Certificate Award Ceremony Closing Remarks
Noon Lunch
Afternoon Lecture #1:
Current Harmonization Status of Pre-and Post-Market Regulation in Each Economy (continued) 		Lecture #4: Adverse Event Reporting

Group Practice:
IMDRF Terminologies for Medical Device Adverse Event
(1) Group Discussion
(2) Group Presentation 		Manufacturing Site Visit
(optional only for regulators)
Icebreaker Activities
Lecture #2:
Medical Device and IVD Definition and Classification + Group Practice
Evening Welcome Reception
Time Topic Speaker 
08:30 – 08:50 Registration  
08:50 – 09:05 Opening Remarks TFDA:
TBD
Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), Chinese Taipei

MD/GRM PWA
Co-Champion:
Ms. Ayumi Endo
Office Director, Office of Asia Training Center and International Cooperation (OAIC), Pharmaceuticals and Medical Devices Agency (PMDA), Japan

GRM PWA Co-Organizer:
Mr. 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
09:05 – 09:15 Group Photo  
09:15 – 09:30 Roadmap and Core Curriculum of GRM/MD PWA GRM PWA:
Ms. Tomoko Tanaka
Coordinator, OAIC, PMDA, Japan

MD PWA:
Mr. Kazuyoshi Takatori
Special Appointed Staff, OAIC, PMDA, Japan
09:30 – 09:50 Coffee Break  
09:50 – 10:00 Introduction of TFDA MD CoE Training Program Mr. Hsiu-Te Lin
Section Chief, Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei
10:00 – 12:00 Lecture #1: 
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy 		20 min per economy    
12:00 – 13:30 Lunch  
13:30 – 14:30 Lecture #1: 
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy 		20 min per economy
14:30 – 14:50 Lecture #1: 
Current Harmonization Status of Pre- and Post-Market Regulation in Each Economy
(Q&A) 		Representatives from each economy
14:50 – 15:10 Coffee Break  
15:10 – 15:40 Icebreaker Activities Moderator 
15:40 – 17:00 Lecture #2: Medical Device Definition and Classification
  • Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ (GHTF/SG1/N071:2012)
  • Principles of Medical Device Classification (GHTF/SG1/N77:2012)
  • Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (IMDRF/IVD WG/N64FINAL:2021) G roup Practice
Group Practice 		Dr. Sheng-Hui Liao
Senior Engineer, Office of Medical Device Evaluation, Center for Measurement Standards, ITRI, Chinese Taipei
17:30 – 19:30 Welcome Reception  
*Day 1, Lecture #1 will be open to the public.
Time Topic Speaker 
09:00 – 09:30 Registration  
09:30 – 10:00 Lecture #3: Review of Essential Principles of Medical Device Safety & Performance and Principles of Conformity Assessment
  • Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (IMDRF/GRRP WG/N47FINAL:2024 (Edition 2))
  • Principles of Conformity Assessment for Medical Devices (GHTF/SG1/N78:2012)
 Mr. Naoki Morooka
Senior Manager, Quality Assurance Dept., Medical Systems Division, Shimadzu Corporation, Japan
10:00 – 12:00 Group Practice: MD Case Study (1 case)
Case Study Introduction (10 min)
Group Discussion (50 min)
Coffee Break (15 min)
Group Presentation (30 min)
Q&A (15 min) 		Ms. Pei-Ting Sarah Chou
Supervisor & Consultant / Founding Board of Director, Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, Chinese Taipei
12:00 – 13:30 Lunch  
13:30 – 14:30 Lecture#4: Adverse Event Reporting
  • Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices (GHTF/SG2/N54R8:2006)
  • IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (IMDRF/AE WG/N43FINAL: 2020 (Edition 4) and IMDRF/AE WG/N43FINAL:2025 Updated Annexes)
 Ms. Yu-Hsuan Yang
Specialist, Taiwan Drug Relief Foundation (TDRF), Chinese Taipei
14:30 – 14:50 Coffee Break  
14:50 – 16:00 Group Practice: IMDRF Terminologies for Medical Device Adverse Event
Group Discussion (30 min)
Group Presentation (30 min)
Q&A (10 min) 		Ms. Yu-Hsuan Yang
Specialist, TDRF, Chinese Taipei
Time Topic Speaker 
09:00 – 09:40 Registration  
09:40 – 10:40 Lecture #5: Clinical Evaluation
  • Clinical Investigation (IMDRF/MDCE WG/N57FINAL: 2019)
  • Clinical Evaluation (IMDRF/MDCE WG/N56FINAL:2019)
  • Clinical Evidence (IMDRF/MDCE WG/N55FINAL:2019)
 Dr. Kevin Wei-I Lee
Clinical Reviewer Division of Medical Devices, CDE, Chinese Taipei
10:40 – 11:00 Expectations from the Workshop and Next Steps
  • TFDA (3 mins)
  • APEC RHSC MD PWA Co-Champion (3 mins)
  • APEC RHSC MD PWA Sub-Champions (3 mins each)
  • Members of the program committee or participants (2 mins each)
 TFDA:
TBD
Division of Medical Devices and Cosmetics, TFDA, MOHW, Chinese Taipei

MD PWA Co-Champion:
Mr. Kazuyoshi Takatori
Special Appointed Staff, OAIC, PMDA, Japan
11:00 – 11:30 Coffee Break  
11:30 – 12:15 Certificate Award Ceremony TBD
TFDA, MOHW, Chinese Taipei
12:15 – 12:30 Closing Remarks TBD
TFDA, MOHW, Chinese Taipei
12:30 – 12:40 Group Photo  
12:40 – 13:30 Lunch  
13:30 – 16:00 Manufacturing Site Visit Regulators Only
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