Time | Topics | Speakers |
09:30 - 10:00(30‘) | Registration (등록) | |
10:00 - 10:05(5‘) | Opening Remarks (개회사) | Sunhee Lee General Director NIFDS, MFDS |
10:05 - 10:10(5‘) | Group Photo (단체 사진 촬영) | - |
Session Ⅰ. Modernization of Medical Device Regulations for Industry 4.0 4차 산업혁명 시대 도래에 따른 의료기기 규제 선진화 Chair : Miok Yun(Director, Cardiovascular Devices Division, NIFDS) | ||
10:10 - 10:40(30‘) | Definition and Regulatory Perspective on Personalized Medical Devices 개인 맟춤형 의료기기의 정의 및 규제 전망 | Elizabeth McGrath Director Conformity Assessment Medical Devices Branch, TGA |
10:40 - 11:10(30‘) | Regulatory Perspective on Digital Healthcare in Canada 캐나다 디지털 헬스케어의 규제 전망 | David Boudreau Executive Director Medical Device Bureau, Health Canada |
11:10 - 11:40(30‘) | Regulatory Perspective on Digital Healthcare Innovation Action Plan in U.S. | William M. Sutton Assistant Country Director U.S. FDA China Office |
11:40 - 12:10(30‘) | Q&A (질의·응답) | All Participants |
12:10 - 13:40(90‘) | Lunch (중식) | All Participants |
Session Ⅱ. Adaptation towards the Changes in Medical Device Regulations 의료기기 규제 변화에 따른 대응 Chair : Minhong Jang(Co-Founder & Chief Operating Officer, Lunit) | ||
13:40 - 14:10(30‘) | Pre-Cert Pilot Program by U.S. FDA | Kate Hyeongjoo Kim Director of Regulatory Strategy & Innovation, Johnson & Johnson Medical Device Companies, APAC |
14:10 - 14:40(30‘) | Clinical Use of AI | Kwangjoon Kim Assistant Professor Department of Internal Medicine Yonsei University College of Medicine |
14:40 - 15:10(30‘) | The Strategy and Practice to new IVDR | Adelheid Schneider Regional RA and Quality Manager Roche Diagnostics, APAC |
15:10 - 15:40(30‘) | Q&A (질의·응답) | All Participants |
15:40 - 16:00(20‘) | Coffee Break (휴식) | All Participants |
Session Ⅲ. Challenges & Opportunities in Asian Medical Device Market 아시아 의료기기 시장에 대한 도전과 기회 Chair : Leslie Kim(Director, RAQA & Reimbursement, Stryker Korea) | ||
16:00 - 16:30(30‘) | Understanding of ASEAN Medical Device Directive(AMDD) | Jason Guo Director RA, Quality and Compliance Abbott Medical, APAC |
16:30 - 17:00(30‘) | Understanding of Medical Device Regulations in China | Hangsik Yim Team Leader Korea Testing & Research Institute |
17:00 - 17:30(30‘) | Q&A (질의·응답) | All Participants |
17:30 - 17:35(5‘) | Closing Remarks (폐회사) | Hyeonjoo Oh Director General MD Evaluation Department NIFDS, MFDS |