AHC-SCH Medical Device CoE Pilot Training
- Greg LeBlanc
Director,
Regulatory Affairs and Quality Systems,
Cook Medical -
- Subject 1. Clinical Evaluation
- Lecture 1: Clinical evaluation and evidence for medical devices
- Subject 1. Clinical Evaluation
- Hwan Sub Lim
Chief Medical Director,
Laboratory medicine,
Seoul Clinical Laboratories -
- Subject 1. Clinical Evaluation
- Lecture 2: Clinical evaluation and evidence for IVD medical vices
- Untact Conference 3: In Vitro Diagnostic Device in Laboratory Practice Experience for COVID‐19 realtime PCR
- Subject 1. Clinical Evaluation
- Yong Ho Lee
Lead Auditor
Medical Device Team
SGS Korea -
- Subject 2: Quality Management System
- Lecture 1: Overview of ISO13485/2016
- Subject 2: Quality Management System
- Doug Reimer
Senior Director,
Regulatory Compliance,
Johnson & Johnson -
- Subject 2: Quality Management System
- Lecture 2: General Understanding of Medical Device Single Audit Program.
- Best practice 2: Medical Device Manufacturer Perspectives ‐ MDSAP.
- Subject 2: Quality Management System
- Eric Woo
Regional Director,
Asia Pacific
ECRI -
- Subject 2: Quality Management System
- Lecture 3: MDV‐QMS intersection
- Subject 2: Quality Management System
- Sun Young Jeong
Head Manager,
RA Department
SD Biosensor -
- Subject 2: Quality Management System
- Best practice 1: Medical Device Manufacturer Perspectives ‐ ISO 13485
- Subject 2: Quality Management System
- Naoki Morooka
Vice-Division Manager,
Regulatory and Safety Division,
JIRA -
- Subject 3: Medical Device Vigilance
- Lecture 1: Introduction to Medical Device Adverse Events
- Subject 3: Medical Device Vigilance
- Ishikawa Hiroshi
Technical Advisor,
Quality and Safety Department,
PMDA -
- Subject 3: Medical Device Vigilance
- Lecture 2: IMDRF Terms & Codes
- Lecture 3: Exploration of IMDRF Adverse Event Terminology Web Browser
- Subject 3: Medical Device Vigilance
- Frances Richmond
Director and Professor,
D K Kim International Center for Regulatory Science,
University of Southern California -
- Untact Conference 1: Practical application of clinical evaluation in COVID‐19 Regulatory Approval (including EUA)
- Hyeonho Kim
Deputy Director,
Medical Device Safety Bureau,
MFDS -
- Untact Conference 1: Practical application of clinical evaluation in COVID‐19 Regulatory Approval (including EUA)
- Danelle Miller
VP, Global Regulatory Policy & Intelligence,
Regulatory Policy & Intelligence,
Roche -
- Untact Conference 2: Practical application of QMS in COVID-19 realtime PCR Manufacture
- Jeff Boone
Vice President,
Quality Management,
Roche -
- Untact Conference 2: Practical application of QMS in COVID-19 realtime PCR Manufacture
- Hyuk Min Lee
Professor,
Laboratory medicine,
Yonsei University-Severance -
- Untact Conference 3: In Vitro Diagnostic Device in Laboratory Practice Experience for COVID‐19 realtime PCR