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2012 APEC-AHC-AHWP Joint Workshop on Medical Device Combination Workshop (Nov.4th)

Agenda 【Date:2013-01-11】 unit:醫療器材及化粧品組

2012 APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products  

Sunday, November 4, 2012

Venue: Room 101, 1F, Taipei International Convention Center (TICC)

Time

Session

Speaker/Panelist/Moderator

08:30 – 09:00

Opening RemarkObjective and expected outcome of the workshop

 

 

 

Opening Remark by AHC Director (video)

 

 

Photo Session

Ms. Li-Ling Liu,

AHWP Vice Chair,

Director, Division of Medical Device and Cosmetics, TFDA, DOH, Chinese Taipei

 

Dr. Kwang-Ho Lee

Director, APEC Harmonization Center/KFDA, Korea

 

09:00 – 09:30

Keynote: Updates on APEC

Mr. Mike Ward,

Chair of APEC RHSC/ Health Canada, Canada  

09:30 – 11:10

 

Current Regulatory Perspectives and Challenges of APEC Economies on Regulating Medical Device Combination Products

Speakers

Moderator

 

 

 

Mrs. Elizabeth Baker, MHRA, UK

 

Ms. Janet Trunzo,

AdvaMed, USA

Ÿ           USA 

Mr. John (Barr) Weiner,

FDA, USA

Ÿ           Japan

 

Dr. Yoichi Onodera,

PMDA, Japan 

Ÿ           Korea

Mr. Young-Min Kim,

KFDA, Korea

Ÿ           China

Mr. Lian-Chun Yang,

SFDA, China

Ÿ           Chinese Taipei : Survey Results of all APEC Economies

Dr. Hsien-Yi Lin,

TFDA, Chinese Taipei

11:10 – 11:40

Tea Break

11:40 – 12:40

The European Approach

 

Speakers

Mrs. Elizabeth Baker, MHRA, UK

 

Dr. Gert Bos,

BSI, UK

Moderator

Ms. Janet Trunzo,

AdvaMed, USA

 

Mrs. Elizabeth Baker, MHRA, UK

12:40 – 13:40

Lunch

13:40 – 14:30

Panel Discussion Current Regulatory Perspectives and Challenges of APEC Economies on Regulating Medical Device Combination Products

All speakers and moderators from previous session

 

14:30 – 15:00

Tea Break

15:00 – 16:00

Case Studies of Combination Products Regulated as Medical Devices

Ÿ           Drug-eluting stent

Speakers

 

Ms. Geraldine Finn,

Medtronic, USA

Moderator:

 

Mr. Michael Gropp, Medtronic, USA

Ÿ           Wound dressings with antibacterial properties

Mr. Scott Sardeson,

3M, USA

Ÿ           Antibacterial orthopedic and neurological devices

Ms. Karen Sylvia,

Johnson & Johnson, USA

Panel Discussion and Q&A

 

16:00 – 17:30

Future direction: Potential Path Toward Convergence

Ÿ           Definition

Ÿ           Clinical Investigation (IDE)

Ÿ           Premarket Review (PMA)

Ÿ           GMP

Ÿ           Post Market Surveillance

Ÿ           International Cooperation

Ÿ           Industry Perspective

Speakers 

 

Dr. Sethuraman Rama

HSA, Singapore

 

Mr. John (Barr) Weiner ,

FDA, USA

 

Ms. Janet Trunzo,

AdvaMed, USA

Moderator 

 

Ms. Lindsay Tao,

Johnson & Johnson, China

 

Mr. John (Barr) Weiner , FDA, USA

 

Panel Discussion and Q&A

 

17:30 – 17:50

Summary and Outcome of Workshop

Ms. Lindsay Tao,

Johnson & Johnson , China

Mr. John (Barr) Weiner,

FDA, USA 

17:50 – 18:00

Closing Remark

Ms. Li-Ling Liu,

AHWP Vice Chair,

Director, Division of Medical Device and Cosmetics, TFDA, DOH, Chinese Taipei

18:00

End of APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products