Conference & Workshop
【Update Date:2013-01-11】unit:醫療器材及化粧品組
2012 APEC Advanced Workshop of Good Review Practice on Medical Products
Tuesday, November 6, 2012
Time
Subjects
Speakers/Panelists
13:00-13:30
Registration
13:30-13:45
Opening Remarks
Jaw-Jou Kang
Director General,
Food and Drug Administration
Department of Health, Chinese Taipei
13:45-14:00
Group Photo
All Chairpersons/Speakers/Panelists and VIPs
Session A. Review of 2011 APEC Basic GReVP Workshop
Chair: Mike Ward
Chairman, APEC LSIF Regulatory Harmonization Steering Committee (RHSC) and Manager, Health Products and Food Branch, Health Canada, Canada
14:00-15:00
Review of Findings from Basic GReVP
Mike Ward
Chairman, APEC LSIF Regulatory Harmonization Steering Committee (RHSC) and Manager, International Programs, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada﹐ Canada
Li?Ling Liu
Director, Division of Medical Devices and Cosmetics
15:00-15:30
Coffee Break
Session B. Quality System for Reviewers
Chair: Deborah Jansen
Center Quality Manager, Center for Biologics Evaluation and Research, US FDA, USA
David Cummings
Associate Director for Quality, Center for Drug Evaluation and Research, US FDA, USA
Co-Chair: Yuwadee Patanawong
Senior Expert, Medical Devices Safety, Thailand FDA, Thailand
15:30-17:00
Introduction to Quality Systems- What is a Quality System and Why Have One
Deborah Jansen
Center Quality Manager,
Center for Biologics Evaluation and Research, US FDA, USA
18:30
Reception Dinner
Wednesday, November 7, 2012
07:30-08:00
08:00-09:30
Quality Systems Applied to Regulatory Review
Caroline Vanneste
Project Manager, Therapeutic Products Directorate, Health Canada, Canada
Associate Director for Quality,
Center for Drug Evaluation and Research, US FDA, USA
Naoyuki Yasuda
International Planning Director, Minister’s Secretariat, Ministry of Health, Labour and Welfare, Japan
Aimad Torqui
Policy Advisor / Alternate CMDh member
Medicines Evaluation Board, EU
09:30-10:00
Current Conditions and Challenges
Larry Liberti, MS, RPH, RAC
Executive Director, Centre for Innovation in Regulatory Science
10:00-10:15
10:15-10:35
Practical Next Steps-Introduction
10:35-11:05
Breakout Sessions:
Common Elements
Neil McAuslane
Director, Centre for Innovation in Regulatory Science
Meir-Chyun Tzou
Director, Division of Drugs and New Biotechnology Products, Food and Drug Administration, Department of Health, Chinese Taipei
Self-Study
Chao-Yi Wang
Deputy Director, Division of Drugs and New
Biotechnology Products, Food and Drug
Administration, Department of Health,
Chinese Taipei
Prioritizing Opportunities
Pei-Weng Tu
Senior Technical Specialist, Division of Medical Devices and Cosmetics
Addressing Opportunities
Soh Zoem Yow
Regulatory Specialist, Health Sciences Authority Singapore
11:05-11:45
Session Reporting
11:45-12:15
Session Summary
12:15-13:30
Lunch
Session C. Key Elements & Strategies of a Good Review
Chair: Caroline Vanneste
Co-Chair: Yi Guo
Reviewer, Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Japan
13:30-14:0
Outline of session, introduction of panel, introduction of good review guiding principles as "key elements of a good review"
14:00-14:30
FDAAA presentation on Pre-Filing Strategies (i.e. scientific / protocol advice, pre-filing meetings with industry)
Mark Goldberger
Member of FDA Alumni Association
Former Director, Office of Drug Evaluation IV, CDER/FDA, USA
14:30-15:00
HC presentation on Review Initiation Strategies (i.e. review kick-off meetings, early identification of "show-stoppers")
EMA presentation on Post-Initial Review Strategies (i.e. use of co-rapporteurs, peer review)
Francesca Cerreta
Scientific Administrator, European Medicines Agency, EU
15:30-15:45
15:45-17:15
How to implement / strengthen pre-filing strategies in your own agency to achieve the key elements of a good review.
Atsushi Tamura
International Coordination Officer, Medical Devices, Pharmaceuticals and Medical Devices Agency, Japan
How to implement / strengthen review initiation strategies in your own agency to achieve the key elements of a good review.
I-Chun Lai
Team Leader, Division of New Drugs Center for Drug and Evaluation, Chinese Taipei
How to implement / strengthen post-initial review strategies in your own agency to achieve the key elements of a good review.
Shelley Tang
Principal, Stellar Consulting Pty Ltd, Former TGA member, Australia
17:15 -17:40
Plenary session to report back on the discussions of the breakout sessions.
17:40 -17:45
Wrap-up
Culture Night
Thursday, November 8, 2012
08:00-09:00
Summary and conclusions from Session C and D
Session D. Critical Thinking and Decision Making : Drugs and Devices (Parallel Session)
09:00-11:30
Drugs
Chair: Florence Houn
Co-Chair of FDA Alumni Association International Network,Former Director, Office of Drug Evaluation III, CDER/FDA
Devices
Chair: Atsushi Tamura
A case study will stimulate discussion on key elements of critical thinking and decision-making in drug review, focusing on issues in safety, efficacy, quality, and the need for risk management.
Panelists:
Florence Houn
Zili Li
Co-Chair of FDA Alumni Association International Network,Former Medical Team Leader, Office of New Drug Review, CDER/FDA
Former Director, Office of Drug Evaluation IV, CDER/FDA
Chi-wan Chen
Member of US FDA Alumni Association International Network, Former Deputy Director, Office of New Drug Quality Assessment, CDER/FDA
I-Chen Sun
Senior Reviewer, Division of New Drugs, Center for Drug Evaluation, Chinese Taipei
Tzong An Wang
Team Leader, Division of New Drugs, Center for Drug and Evaluation, Chinese Taipei
Discuss the elements of critical thinking and a quality decision-making process for device review
Laurent Selles
Senior Coordinator for International Relations, Health Technology and Cosmetics, European Commission, EU
Yi Guo
Ming-Che Wang
Director, Division of Medical Devices, Center of Drug Evaluation, Chinese Taipei
Shelly Tang
Jai-Yen Chen
Reviewer, Division of Medical Devices, Center of Drug Evaluation, Chinese Taipei
Hong-Yi Huang
11:30-12:00
Section Summary (Combined Drug and Device)
12:00-13:00
Session E. Transparency and Interactions: With the Public, Industry/Other Stakeholders and Regulatory Authorities
Chair: Naoyuki Yasuda
Herng-Der Chern
Distinguished Research Fellow, Center for Drug Evaluation, Chinese Taipei
Co-Chair: Laurent Selles
Senior Coordinator for International Relations, Health Technology and Cosmetics, European Commission
Regulatory Specialist, Health Sciences Authority, Singapore
13:00-13:05
Outline and Objectives of Part I
13:05-14:15
Part I Transparency and interaction:
1) with the public
2) with industry and other stakeholders
3) Discussion-I (25 min.)
Chairman, APEC LSIF Regulatory Harmonization Steering Committee (RHSC) and Manager, International Programs, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Canada
14:15-14:25
14:25-14:30
Outline and Objectives of Part II
14:30-16:00
Part II Transparency and interaction:
1) with regulatory agencies
2) Discussion-II (30 Min.)
Yuwadee Patanawong
Yi-Lin Wang
Reviewer, Division of Pharmaceutical Sciences, Center for Drug Evaluation, Chinese Taipei
16:00-16:15
Session F. Conclusion
Chairman, APEC LSIF Regulatory Harmonization Steering Committee (RHSC) and Manager, Health Products and Food Branch, Health Canada
16:15-17:30
Conclusion
Churn-Shiouh Gau
Executive Director, Center for Drug Evaluation, Chinese Taipei
17:30-18:00
Closing Remarks
Shiow-Ing Wu
Deputy Director-General,
Food and Drug Administration,
Department of Health,
Chinese Taipei,