2011 Second Workshop

Home > Training Program > 2011 Second workshop >Program

day1

July 4, 2011 (Monday)

Conference Date/Time	Agenda
09:00 – 09:23	Opening Ceremony Opening Remarks Dr. Seung Hee Kim Director, APEC Harmonization Center(AHC), Republic of Korea Welcoming Address Dr. Yun Hong Noh Commissioner, Korea Food & Drug Administration (KFDA), Republic of Korea Congratulatory Remarks Dr. Bup Wan Kim President, Korea Health Industry Development Institute (KHIDI), Republic of Korea Congratulatory Remarks Dr. Joanna Koh Chair, AHWP Technical Committee, Singapore Congratulatory Remarks Dr. Atsushi Tamura Director, Office of Medical Devices I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
09:23 – 09:30	GROUP PHOTO SESSION
09:30 – 10:00	Keynote Speech The Regulatory System for Medical Devices in Korea SpeakerMr. Seong Ho Kim Director, Medical Devices Policy Division, Medical Device Safety Bureau, KFDA
10:00 – 10:40	Session 1: Overview Overview of GHTF Regulatory Model SpeakerMr. Kentaro Azuma Deputy Director, Office of Medical Device Evaluation, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare(MHLW)
10:40 – 11:00	REFRESHMENT BREAK
11:00 – 12:30	Session 2: QMS/GMP system and audit: ModeratorMs. Elisabeth George Vice President, Global Government Affairs, Regulations & Standards, Philips Healthcare Medical device QMS/GMP system and audit SpeakerMr. Kenichi Ishibashi Inspector, Office of GMP/QMS Inspection, PMDA Medical device GMP system and audit in Korea Mr. Jae-Ho Jung Deputy Director, Medical Device Quality Division, KFDA QMS/GMP and audit Ms. Elisabeth George Vice President, Global Government Affairs, Regulations & Standards, Philips Healthcare
12:30 – 13:50	LUNCH ( * Invited luncheon at Alsace-Province (2nd floor))
13:50 – 15:20	Session 3: Essential Principle: ModeratorMr. Michael Gropp Special Representative, AdvaMed Representative of US Industry, GHTF Steering Committee Use of Essential Principles in Defining Safety and Effectiveness Requirements SpeakerMs. Nancy Shadeed(* Video Conference) Manager, Device Licensing Division, Medical Devices Bureau, Health Canada Essential Principles conformity checklist, Approval Standards and Review Guidelines Dr. Atsushi Tamura Director, Office of Medical Devices I, PMDA Essential Principles conformity checklist, case of Computer Tomography Mr. Hiroshi Ishikawa Vice Chair, GHTF committee / Member, GHTF Steering Committee Japan Federation of Medical Devices Associations (JFMDA)
15:20 – 15:40	REFRESHMENT BREAK
15:40 – 17:40	Session 4: STED: ModeratorMr. Hiroshi Ishikawa Vice Chair, GHTF committee / Member, GHTF Steering Committee Japan Federation of Medical Devices Associations (JFMDA) Review of medical device applications using STED SpeakerMr. Yutaka Tomioka Reviewer, Office of Medical Devices I, PMDA Comparison & Mapping of STED with CSDT Dr. Huifen Bai Senior Regulatory Specialist, Medical Device Branch, Health Products Regulation Group, HSA The STED and Conformity Assessment Mr. Michael Flood Principal, Locus Consulting Pty Ltd. STED Case Study Mr. Michael Morton Chair, AdvaMed Premarket Approval (PMA) Working Group, AdvaMed US Industry Representative, GHTF SG1
17:40 – 18:00	Q & A

day2

July 5, 2011 (Tuesday)

Conference Date/Time	Agenda
09:30 – 10:30	Session 5: Adverse Event Reporting: ModeratorDr. Gyu Ha Ryu Director, Medical Device Evaluation Department, KFDA Implementation of Adverse Event Reporting SpeakerMs. Yuka Sugamura Officer, Medical Device Safety Division & Medical Safety Information Group, Office of Safety 1, PMDA Adverse Event Reporting Ms. Chadaporn (Miang) Tanakasemsub AP QA/RA VP, Zimmer
10:30 - 10:50	REFRESHMENT BREAK
10:50 – 12:50	Session 6: Experiences of GHTF guidance implementation: ModeratorMr. Kentaro Azuma Deputy Director, Office of Medical Device Evaluation, Pharmaceutical and Food Safety Bureau, MHLW Experience in Canada SpeakerMs. Nancy Shadeed(* Video Conference) Manager, Device Licensing Division, Medical Devices Bureau, Health Canada Experience in Japan Dr. Atsushi Tamura Director, Office of Medical Devices I, PMDA Experiences in Singapore Dr. Rama Sethuraman Senior Regulatory Specialist, Medical Device Branch, Pre-Marketing Division, Health Products Regulation Group, HSA Review of Technical Documents in KFDA Mr. Hae Dae Park Senior Researcher, Medical Device Evaluation Department, KFDA
12:50 – 13:50	LUNCH ( * Invited luncheon at Alsace-Province (2nd floor))
13:50 – 15:50	Session 7: GMDN: ModeratorMr. Leighton Hansel Director, Regulatory Affairs Abbott Quality & Regulatory Abbott Laboratories GHTF guidance SpeakerMr. Hiroshi Ishikawa Vice Chair, GHTF committee / Member, GHTF Steering Committee Japan Federation of Medical Devices Associations (JFMDA) UDI and US Mr. Thomas Edward Werthwine Global Process Owner, Auto ID Technology and Data Standards, Johnson & Johnson Health Care Systems / AdvaMed Utilization of GMDN in combination with GHTF risk-base classification rule Mr. Tomomichi Nakazaki Director, Medical Devices Regulatory Affairs/Allergan Japan K.K., JFMDA
15:50 – 16:30	REFRESHMENT BREAK
16:30 – 17:30	Session 8: Panel Discussion and Q&A: ModeratorDr. Atsushi Tamura (PMDA) & Mr. Michael Gropp (AdvaMed/GHTF SC) PanelistsMr. Kentaro Azuma (MHLW) Mr. Hiroshi Ishikawa (JFMDA / GHTF SC) Mr. Tomomichi Nakazaki (JFMDA) Dr. Lindsay Tao (J&J / AHWP) Dr. Joanna Koh (HSA / AHWP)
17:30 – 17:40	Concluding Remarks & Recommendations Dr. Atsushi Tamura (PMDA) & Mr. Michael Gropp (AdvaMed/GHTF SC)
17:40 – 17:50	CLOSING ADDRESS Dr. Seung Hee Kim (Director, APEC Harmonization Center)
17:50 – 17:55	GROUP PHOTO SESSION
18:00 – 20:00	Dinner Reception (for AHC and Asian Harmonization Working Party Technical Committee) - Hosted by Dr. Yun Hong Noh, Commissioner of Korea Food and Drug Administration (KFDA)