2014 GS1 헬스케어컨퍼런스개요 대한상공회의소유통물류진흥원 월 Ⅰ. 행사개요 1 Ⅱ. 주요행사내용 2 Ⅲ. 일자별세부프로그램 3

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1 2014 GS1 헬스케어컨퍼런스개요 월 목차 Ⅰ. 행사개요 1 Ⅱ. 주요행사내용 2 Ⅲ. 일자별세부프로그램 3 GS1 (Global Standards #1) 비영리유통물류국제표준화기관. ( 벨기에본부 ) 바코드 /RFID 등유통정보화를위한표준기술개발, 보급 GS1 Korea ( 대한상공회의소 ) 1988년부터대한상의는 GS1 Korea로서국내정부및기업유통물류정보화, 표준화지원 대한상공회의소유통물류진흥원

2 * USDM : 글로벌의약품 / 의료기기이력추적솔루션컨설팅회사 ** EDQM (European Directorate for the Quality of Medicines & HealthCare) [ 14 년 3 월현재 ] - 1 -

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4 주요연사 Miguel Lopera, GS1 CEO Jay Crowley, USDM* Vice President * USDM : 글로벌의약품 / 의료기기이력추적솔루션컨설팅회사 임종훈, 한미약품전무 ( 한미IT 대표이사 ) Grant Courtney, 유럽스테이크홀더모델 (European Stakeholer Model) Mark Brommeyer, 호주 e헬스이행국 SCM 리더 Ulrike Kreysa, GS1 Healthcare Vice President * GHX : 보건의료산업의약품공급망관리솔루션제공업체 - 3 -

5 Tuesday, 1 April 2014 From 7:30 8:00 9:30 Registration and welcome coffee PRIMER SESSION Introduction to GS1Healthcare global standards across the world A starter session on GS1 standards in AIDC (Automatic Identification and Data Capture), Traceability, GDSN, Public Policy and ecommerce 9:30 10:00 Welcome coffee OPENING PLENARY SESSION Unique Device Identification (UDI) 10:00 12:30 10:00 10:20 10:20 10:50 10:50 11:30 UDI aims at establishing a single device identification system that is consistent, unambiguous, standardised and globally harmonised. At the same time, similar regulations are being developed in other parts of the world. The opening session of the conference provides an overview of the status quo around the world. Welcome to conference Miguel Lopera, CEO and President, GS1 Global Office Kim Kyung Jong, President, GS1 Korea Confirmed Progress on UDI in Korea Korean FDA Invited The UDI Rule - Details of the new rule Jay Crowley, VP UDI Practice, USDM formerly Patient Safety Advisor, U.S. FDA Confirmed 11:30 11:50 Gao Guobiao, Assistant Director General, CFDA,China Invited 11:50 12:10 Mark Brommeyer, Manager Supply Chain, NEHTA, Australia Confirmed 12:10 12:30 Joanna Koh, Chair, Technical Working Party Confirmed Committee, Asian Harmonisation 12:30 2:00 Lunch and Poster Session or Public Policy Working Lunch Medical Devices Regulatory requirements and initiatives related to medical devices around the world normally a closed group, it is only open for this session (a Public Policy session focused on Pharmaceuticals will take place in the Implementation Reality Session this afternoon) - 4 -

6 IMPLEMENTATION REALITY Round 1 2:00 3:30 Three concurrent breakout sessions on how to implement UDI and the regulatory requirements and developments for pharmaceutical products across the world. The smaller groups allow for a more involved exchange between participants, speakers and moderators. Technical background, short presentations of case studies, panel discussions, step-by-step procedures and detailed discussions. Regulatory requirements and initiatives related to pharmaceuticals around the world normally a closed group, it is only open for this session (a Public Policy Working Lunch, focused on Medical Devices, will take place earlier this day) Coffee break and Poster Session 3:30 4:00 Visit the exhibition on special teams about their work projects and speak directly with the 4:00 5:30 IMPLEMENTATION REALITY Round 2 Second round of the breakout sessions, the groups: switch of topics between 5:30 7:30 International Government Healthcare Supply Chain ThinkTank ON INVITATION ONLY Open to international government healthcare organisation Discussions will be held under the Chatham House Rule - 5 -

7 Wednesday, 2 April :30 9:00 Welcome coffee and Poster Session PLENARY SESSION Traceability 9:00 12:30 9:00 9:25 9:25 9:50 9:50 10:15 Traceability is today in the focus of many regulatory bodies and worldwide regulations and activities are evolving. This session discusses traceability and authentication, counterfeiting and the need to get the original product to the patient US federal regulation on track & trace Connie Jung, Pharmacologist, U.S. FDA Invited Serialisation and traceability Goun Lee, Deputy Director Division Office of Healthcare Policy, Korean Ministry of Health & Welfare Confirmed APEC track & trace systems working group Mark Paxton, Regulatory Counsel, U.S. FDA Confirmed 10:15 10:40 Traceability for pharmaceuticals Prof. Saleh A. Bawazir, VP for Drug Affairs, Saudi FDA Confirmed 10:40 11:10 Coffee break and Poster Session 11:10 11:35 The European stakeholder model Grant Courtney, Serialisation & Security Manager, ESM Confirmed 11:35 12:00 The etact system Francois Xavier Lery, EDQM, Council of Europe Confirmed 12:00 12:30 12:30 2:00 Traceability implementation use case in Korea Jonghoon Lim, Executive Director, Hanmi Pharmaceutical Co. Ltd Confirmed Lunch and Poster Session or HPAC Working Lunch Experience of hospitals in implementation - 6 -

8 IMPLEMENTATION REALITY Round 1 2:00 3:30 Two concurrent breakout sessions on how to implement traceability regulations and best practice examples from leading US hospital groups on implementation of standards. The smaller groups allow for a more involved exchange between participants, speakers and moderators. Technical background, short presentations of case studies, panel discussions, step-by-step procedures and detailed discussions. Participants can chose from two sessions. 3:30 4:00 Coffee break and Poster Session of the GS1 Member Organisations 4:00 5:30 IMPLEMENTATION REALITY Round 2 Participants select a second topic from the breakout sessions: 7:00 Networking event Thursday, 3 April :30 9:00 Welcome coffee PLENARY SESSION Hospital implementation 9:00 12:00 9:00 9:30 9:30 10:00 A session for both suppliers and providers, to learn about hospital implementations from around the world ICT Use Case for Patient Safety: SNUBH s Experience Dr. Kee-Hyuck Lee, Center for Medical Informatics, Seoul National University Bundang Confirmed Level-below-the-each Prof. Su-Yu Chien, Changhua Christian Hospital, Taiwan Confirmed - 7 -

9 10:00 10:30 Coffee break and Poster Session 10:30 12:40 CLOSING PLENARY Patient safety worldwide 10:30 11:00 Transforming the supply chain Ms S C Chiang, The Hong Kong Hospital Authority Confirmed 11:00-11:15 Better Procurement, Better Value, Better Care the NHS mandate for GS1 Chris Doyle, GS1 UK Confirmed 11:15 12:00 Roundtable with hospitals: How can standards support hospitals to improve patient s care Confirmed 12:00 12:10 The next global GS1 Healthcare conference in Scandinavia invitation Lars Kyed, CEO, GS1 Denmark Confirmed 12:10 12:20 Closing remarks GS1 Healthcare Tri-chairs Afternoon Site visits to: - Hanmi Pharm. Co., Ltd (manufacturer) - TaeJeon Pharm Wholesale Co., Ltd. (wholesaler) - Seoul National University BUNDANG Hospital (university hospital) - 8 -