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Medical Device Vigilance (NIDS)

2018 AHC-NIDS Medical Device Vigilance CoE Pilot Training

September 13-14, 2018
National Institute of Medical Device Safety Information (NIDS), Seoul, Republic of Korea

 

 

Training objective:

The training will focus on providing an overview of APEC Center of Excellence (CoE) activities in the field of Medical Device Vigilance, and highlight the efforts of global regulatory convergence for medical device by learning the international guidance from GHTF/IMDRF and AHWP.

The curriculum will enrich the regulatory capacity which required to bring safe, efficacious and quality medical device to patients as rapidly as possible. In addition, the pilot CoE can facilitate regulatory convergence and promote dialogue with a view towards sharing understanding in global trends and best practices in particular to the surveillance and monitoring.

Time

Topic

September 13, 2018 (Thursday)

09:30-10:00

Registration

Welcome and Introduction

10:00-10:10

Opening Remarks

Hee Kyo Jeong (NIDS)

10:10-10:30

Group Photo & Break

10:30-10:45

Overview of APEC Medical Device Vigilance Activities

-       Outcomes and Key Learnings from 2017 training

-       Context and Goals for the AHC-NIDS Pilot CoE Program

 

Participant introductions

Hyeonho Kim (MFDS)

Session I: Introduction on Medical Device Vigilance

Highlight the importance of roles and responsibilities for the stakeholders in the field of Medical Device Vigilance, and introduce the beneficial outcome of the global harmonization efforts by understanding MedDRA.

10:45-11:15

Roles and responsibilities of each stakeholder in the field of Medical Device Vigilance

Eric Woo (ECRI)

11:15-11:45

Understanding MedDRA

Patrick Revelle

(MedDRA)

11:45-13:00

Lunch

Session II: Understanding IMDRF Guidelines

In this session, there are two (2) key learnings. (1) we will explore the effective way of sharing and exchanging MDV information among APEC economies by learning the IMDRF/NCAR WG/N14 FINAL: 2017 (Edition2) which released in September 2017. and (2) Introduction on IMDRF/AE WG/N43 FINAL: 2017 (Edition 2) will explain the harmonized terminologies of the AE reports for Medical Device. We will learn how it could be implemented in MDV practices. Furthermore, Sharing the progress of on-going development for the ‘Patient problem terms/codes (Annex E)’ and ‘Component terms/codes (Annex F)’ will enhance the awareness of accessible information for the future MDV.

13:00-13:50

Integration of MDV system - How to exchange information between National Competent Authorities

Ishikawa Hiroshi

(PMDA)

13:50-14:40

IMDRF AE Terminology

Ishikawa Hiroshi

(PMDA)

14:40-15:00

Break

Session III: Case studies & Breakout discussion

Breaking into small groups, participants will discuss how the cases impacted to public health and what are the following actions that needed to be taken as the NCA’s point of view.

15:00-15:15

Introduction on cases

Lead: You Kyoung Lee

(SCH University)

Facilitator: Eric Woo (ECRI)

15:15-16:30

Case studies & Breakout discussion: Considering the impacts on public health; the what are the following actions to be taken as the NCA’s point of view

16:30-16:50

Sharing each group consensus

16:50-17:00

Summary of Breakout discussion, questions and answers

17:00-17:05

Day 1 closing

September 14, 2018 (Friday)

Session IV: Medical Device Vigilance; from Data to Information

09:10-09:50

Database construction in MDV for detecting national trend; is it really need and possible?

Ju Han Kim (SNU)

09:50-10:30

Horizon Scanning – how it could be effective to Medical Device Surveillance

Eric Woo(ECRI)

10:30-10:50

Break

Session V: Best Practices in MDV System

10:50-11:30

Operational experiences and challenges; How to move forward

-       Korea Perspective - Medical Device Safety Monitoring Center (MDSMC)

     MDSMC: To promote adverse event reporting of medical institutions and to establish an advanced safety management system, Ministry Food and Drug Safety (MFDS) has been carrying out the ‘Medical Device Safety Information Monitoring Center’ project since 2011

-       Industry perspective

 

Bum Sun Kwon

(Dongkuk University)

 

Terry Song (Boston Scientific)

 

11:30-12:00

Panel discussion; Benefits and challenges of AE reporting

Lead: Hyeonho Kim (MFDS)

Panelist:

Bum Sun Kwon

(Dongkuk University)

Terry Song (Boston Scientific)

Conan Tsang

(Department of Health, Hong Kong)

Ishikawa Hiroshi

(PMDA)

12:00-12:10

Closing Remarks

Na Kyoung Kim

(AHC/NIFDS, MFDS)

12:10-13:00

Lunch

Site Visit

13:00-16:30

Site Visit - Samsung Electronic Innovation Center

16:30-

Adjourn