IMDRF-DITTA Joint Virtual Workshop

Thursday 9th September 2021   |   20:00 KST

REGISTRATION

PROGRAM

Korea Standard Time Program
20:00 ~ 20:05 Welcoming Remarks by Masaaki Ohtsuka, JIRA, DITTA Chair
20:05 ~ 20:10 Opening Remarks by Oh-Sang Kwon, IMDRF 2021 Chair, MFDS, Korea
20:10 ~ 20:30

Part 1 :  Background and introduction to UDI and IMDRF guidance documents

  • Moderator: Chung-Keun Lee, MFDS
  • Session 1: Vision of a global UDI system
  • 1. USA  :  Erin CuttsU.S. FDA
  • 2. EU  :  Erik Hansson
  • Session 2: IMDRF UDI Guidance Documents
  • 1. USA  :  Erin CuttsU.S. FDA
  • 2. EU  :  Nada Alkhayat and Orla DalyEuropean Commission
  • 3. Q&A
20:30 ~ 21:10

Part 2 :  Implementation of UDI in different jurisdictions

  • Moderator: Chung-Keun Lee, MFDS
  • 1. Australia  :  Michelle van WijkTGA
  • 2. Brazil  :  Hélio Bomfim de Macêdo FilhoANVISA
  • 3. Japan  :  Kanako SasakiMHLW
  • 4. Q&A
21:10 ~ 21:50

Part 3 :  UDI implementation and importance of harmonization for industry

  • Moderator: Sunny Woo, KMDIA, DITTA
  • 1. DITTA  :   Zita YurkoPhilips
  • 2. GMTA  :   Tania PearsonMedtronic
  • 3. KMDIA  :   Hee-kwon SonOsstem Implant Co., Ltd.
  • 4. USA  :   Kevin CapatchGeisinger Health System
  • 5. Q&A
21:50 ~ 22:20

Part 4 :  Panel discussion on 1) Harmonization of UDI Data element 2) Harmonization of UDI DI trigger

  • Moderator: Annika Eberstein, COCIR, DITTA
  • 1. Panel discussion by the presenters of Part 1, Part 2 and Part 3
  • 2. Conclusion
22:20 ~ 22:30

Closing Remarks

  • 1. Jeong-Rim Lee, MFDS, Korea
  • 2. Annika Eberstein, COCIR, DITTA Vice Chair
* English-Korean simultaneous interpretation is provided during IMDRF-DITTA Joint Virtual Workshop. IMDRF-DITTA 합동 온라인 워크숍에는 영한 동시동역이 제공됩니다.
* Registration will be closed when the number of registration reaches 1,000. If you have any questions for individual Parts of this workshop, please send them at "overseas@jira-net.or.jp". We may be able to reply to some of your questions during the sessions. 사전등록은 선착순 1,000명으로 마감됩니다. 워크숍 각 파트별 내용 관련하여 질문이 있으시다면 "overseas@jira-net.or.jp"으로 보내주시길 바랍니다. 가능하면, 워크숍 중에 보내주신 질문에 대한 답을 할 수 있도록 하겠습니다.
* Find more information on the program here. 프로그램에 대한 자세한 내용은 여기를 클릭하십시오.
Virtual Workshop
TOP