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2012 APEC Advanced Workshop of Good Review Practice on Medical Products (Nov.6th-8th)

Agenda 【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

LiLing Liu

Director, Division of Medical Devices and Cosmetics

Food and Drug Administration

Department of Health, Chinese Taipei

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

Time 

Subjects

Speakers/Panelists 

07:30-08:00

Registration

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 

08:00-09:30

Quality Systems Applied to Regulatory Review

Caroline Vanneste

Project Manager, Therapeutic Products Directorate, Health Canada, Canada 

David Cummings

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

Coffee Break

10:15-10:35

Practical Next Steps-Introduction 

Deborah Jansen

Center Quality Manager, 

Center for Biologics Evaluation and Research, US FDA, USA

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 

Caroline Vanneste

Project Manager, Therapeutic Products Directorate, Health Canada, Canada 

Chao-Yi Wang

Deputy Director, Division of Drugs and New

Biotechnology Products, Food and Drug

Administration, Department of Health,

Chinese Taipei

Prioritizing Opportunities 

Deborah Jansen

Center Quality Manager, 

Center for Biologics Evaluation and Research, US FDA, USA

Pei-Weng Tu

Senior Technical Specialist, Division of Medical Devices and Cosmetics

Food and Drug Administration

Department of Health, Chinese Taipei

Addressing Opportunities 

David Cummings

Associate Director for Quality,

Center for Drug Evaluation and Research, US FDA, USA

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

Project Manager, Therapeutic Products Directorate, Health Canada, Canada 

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" 

Caroline Vanneste

Project Manager, Therapeutic Products Directorate, Health Canada, Canada 

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") 

Caroline Vanneste

Project Manager, Therapeutic Products Directorate, Health Canada, Canada 

15:00-15:30

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

Coffee Break

15:45-17:15

Breakout Sessions:

How to implement / strengthen pre-filing strategies in your own agency to achieve the key elements of a good review. 

Mark Goldberger

Member of FDA Alumni Association

Former Director, Office of Drug Evaluation IV, CDER/FDA, USA

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. 

Caroline Vanneste

Project Manager, Therapeutic Products Directorate, Health Canada, Canada

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. 

Francesca Cerreta

Scientific Administrator, European Medicines Agency, EU

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

Caroline Vanneste

Project Manager, Therapeutic Products Directorate, Health Canada, Canada

18:30

Culture Night 

 


 

 

Thursday, November 8, 2012

Time 

Subjects 

Speakers/Panelists 

07:30-08:00

Registration

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

International Coordination Officer, Medical Devices, Pharmaceuticals and Medical Devices Agency, Japan


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

Co-Chair of FDA Alumni Association International Network,Former Director, Office of Drug Evaluation III, CDER/FDA

Zili Li

Co-Chair of FDA Alumni Association International Network,Former Medical Team Leader, Office of New Drug Review, CDER/FDA

Mark Goldberger

Member of FDA Alumni Association

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 

 

Panelists: 

Laurent Selles

Senior Coordinator for International Relations, Health Technology and Cosmetics, European Commission, EU

Yi Guo

Reviewer, Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Japan

Ming-Che Wang

Director, Division of Medical Devices, Center of Drug Evaluation, Chinese Taipei

Shelly Tang

Principal, Stellar Consulting Pty Ltd, Former TGA member, Australia

Jai-Yen Chen

Reviewer, Division of Medical Devices, Center of Drug Evaluation, Chinese Taipei

Hong-Yi Huang

Reviewer, Division of Medical Devices, Center of Drug Evaluation, Chinese Taipei

11:30-12:00

Section Summary (Combined Drug and Device)

12:00-13:00

Lunch

Session E. Transparency and Interactions: With the Public, Industry/Other Stakeholders and Regulatory Authorities 

Chair: Naoyuki Yasuda

International Planning Director, Minister’s Secretariat, Ministry of Health, Labour and Welfare, Japan

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

Soh Zoem Yow

Regulatory Specialist, Health Sciences Authority, Singapore

13:00-13:05

Outline and Objectives of Part I 

Naoyuki Yasuda

International Planning Director, Minister’s Secretariat, Ministry of Health, Labour and Welfare, Japan 

13:05-14:15

Part I Transparency and interaction:

1) with the public

2) with industry and other stakeholders

3) Discussion-I (25 min.)

 

Francesca Cerreta

Scientific Administrator, European Medicines Agency, EU

Naoyuki Yasuda

International Planning Director, Minister’s Secretariat, Ministry of Health, Labour and Welfare, Japan

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

14:15-14:25

Coffee Break

14:25-14:30

Outline and Objectives of Part II 

Herng-Der Chern

Distinguished Research Fellow, Center for Drug Evaluation, Chinese Taipei

14:30-16:00

Part II Transparency and interaction:

1) with regulatory agencies

2) Discussion-II (30 Min.) 

 

 

Yuwadee Patanawong 

Senior Expert, Medical Devices Safety, Thailand FDA, Thailand

Herng-Der Chern

Distinguished Research Fellow, Center for Drug Evaluation, Chinese Taipei

Yi-Lin Wang

Reviewer, Division of Pharmaceutical Sciences, Center for Drug Evaluation, Chinese Taipei

16:00-16:15

Coffee Break

Session F. Conclusion

Chair: Mike Ward 

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,