Introduction

Aim of SCH CoE Training

  • Design training programs that meet PWA CoE Program Committee’s training objectives in the scope of Total Product Life Cycle of Medical Devices
  • Deliver training programs effectively and promote harmonization and advancement of the use of standards in the assessment of medical devices among APEC region
  • Assess the implementation and outcomes of CoE training and provide suggestions for future regulatory harmonization activities APEC LSIF RHSC
  • Secure programs and a pool of lecturers and experts to disseminate the importance of the use of standards

About training

The 2021 SCH Medical Device CoE Training endeavor to train and educate ourselves of the topics across the total product life cycle of medical devices. The three main subject areas are Clinical Evaluation, Quality Management System and Medical Device Adverse Event. Through this training, we expect to expand our understanding of international standards, harmonize the regulatory systems for medical devices within APEC economies, build reliability on clinical tests conducted for medical devices, and thereby, share the benefits from the development of medical devices and healthcare with APEC economies.

Target Audience

  • Regulators from APEC economies
  • A wider range of stakeholders including academia, industry, etc

Venue

The training will be held virtually via video lectures and Untact Conference, due to COVID-19

Key Dates

Event Date
Registration August 9 – September 8, 2021
Online training
* All training materials are available during online training.
September 1 – 21, 2021


Untact Conference

*Trainees will be invited through Webex

Day 1 September 10, 2021
Day 2 September 17, 2021
Satisfaction Survey
*After participating in 3 VOD lectures, 3 Online activity, and 1 Untact conference, you will be able to conduct a satisfaction survey
September 10 – 21, 2021

Certificate Requirements

  • Certificates of participation will be issued to qualified trainees that have met the following minimum requirements:

    • Completion of 3 or more VOD lectures
    • Participation of 3 or more Online activity
    • Attendance of at least 1 Untact Conference
    • Completion of satisfaction survey

Welcome messages

  • Seungwoo Kim, Ph.D.
    President
    Soonchunhyang University

  • Eung-jin Shin, M.D., Ph.D.
    President
    Soonchunhyang University Bucheon Hospital