Update on Medical Device PWA of RHSC APEC Co-Champion Economies: - PowerPoint PPT Presentation

Nov 04, 2022 •194 likes •334 views

Update on Medical Device PWA of RHSC APEC Co-Champion Economies: Japan PMDA South Korea MFDS USA FDA Priority Work Areas (PWAs) Multi Regional Clinical Trials and Good Clinical Practices Inspections (Japan, Thailand)

Update on Medical Device PWA of RHSC APEC Co-Champion Economies: Japan – PMDA South Korea – MFDS USA – FDA
Priority Work Areas (PWAs) • Multi Regional Clinical Trials and Good Clinical Practices Inspections (Japan, Thailand) • Pharmacovigilance (Korea) • Biotherapeutics (Korea) • Advanced Therapies (Singapore) • Good Registration Management (Chinese Taipei, Japan) • Global Supply Chain Integrity (USA) • Medical Devices (Japan, Korea, USA) – NEW! 2
Medical Device PWA Aims to: • Promote international harmonization initiatives (i.e., IMDRF and former GHTF guidance documents) • Build regulatory capacity and knowledge • Support harmonized implementation efforts among APEC economies 3
Activities since IMDRF-14 • Endorsed Roadmap and Core-Curriculum of Medical Device PWA in Nov. 2018 • Assigned Medical Device Coalitions (AdvaMed and JIRA) as Sub-Champions • Identified Pilot CoEs – CoE pilot program about Medical Device Vigilance conducted by NIDS in Sep. 2018 – More pilot CoEs been endorsed 4
Medical Device PWA Roadmap • Promotes regulatory convergence for medical device regulatory systems • Focuses on training and education efforts related to topics across the Total Product Life Cycle (TPLC) of medical devices: – Premarket – Postmarket – Quality Management System (QMS) 5
Medical Device PWA Roadmap (2) • Under this roadmap: – Co-Champions endorse a Core Curriculum and solicit Sub-Champions – Sub-Champions identify potential CoEs, conduct gap analysis, address key performance indicators (KPIs), etc. – CoEs conduct training programs and workshops – Assessment and feedback are obtained – Additional topics of convergence would be identified as needed 6
PWA Core Curriculum • Annex to the PWA roadmap • “Reference library” of harmonized guidance documents on TPLC topics • GHTF/IMDRF documents are recognized core harmonized guidance documents in Medical Device PWA 7
PWA Core Curriculum (2) • CoEs can select any number of the IMDRF and former GHTF guidance documents from the Core Curriculum to develop training programs and workshops • Co-Champions continuously update Core Curriculum with intersessional approval • Both medical devices and in vitro diagnostic (IVD) medical devices are inclusive 8
Medical Device PWA Structure MFDS, Co-Champions PMDA, FDA AdvaMed & JIRA Sub-Champions (Medical Device Coalition) Centers of CoE I CoE II CoE III CoE etc. Excellence 9
Pilot CoE Applicants Name of Topic institution Pre market QMS Post Market Duke-NUS TBC NEU NIDS PMDA TFDA USC 10
Summary and Next Steps • Sub-Champions assigned and pilot CoEs identified • Overarching roadmap with core curriculum endorsed • Pilot CoEs endorsed and training programs to be conducted starting in April • Launch of RHSC website planned for April 2019 11
Thank you 12

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