Policy Sessions:
Engagement with External Stakeholders Session – December 1, 2020
COVID-19, Impact, response, recovery; Lessons learned from COVID-19 & The Role of the WTO TBT Agreement & GRPs in support of Medical Device Regulatory Convergence were address by experts at the London School of Hygiene and Tropical Medicine, FDA — LATAM Office, WHO, PAHO, CBDL/ALADDIV, Ministry of Economy of Brazil and The Office of the U.S. Trade Representative.
Agenda, Slides Deck, Webinar Recording
Webinar GRPs in Mexico – November 12, 2020
Good Regulatory Practices in Mexico from the perspective of the Executive (CONAMER, DGN, COFEPRIS), Legislative (Chamber of Deputies) and Judicial (Superior Court of Administrative Justice) Powers, including obligations stated at multilateral agreements (TBT, OECD and USMCA). Materials available in Spanish only.
Agenda, Slides deck, Webinar Recording (Audio only available in Spanish).
The Coalition held a series of educational webinars to provide the policy context for Medical Device Regulatory Convergence. Topics included:
- Medical Device International Benchmarks: WHO, IMDRF, MDSAP
- Good Regulatory Practices (GRP)
- Technical Barriers to Trade (TBT)
- International Standards and Conformity Assessment System
- International Medical Device Standardization
Webinar Session 1 – May 26, 2020
Regulatory Convergence and International Benchmarks: WHO, IMDRF, MDSAP.
Agenda, Slides deck, Webinar Recording.
Webinar Session 2 – June 2, 2020
Global Perspectives: GMTA, MDUFA, 21st Century Cures, APEC MD Initiative, GRPs and International Benchmarks: OECD, IDB, ABD, APEC & Advancing Opportunities from the COVID-19 Pandemic.
Agenda, Slides deck, Webinar Recording.
Webinar Session 3 – June 9, 2020
World Trade Organization and TBT Agreement as GRP, International Standards And Conformity Assessment as GRP, International Standards and SDOs for Medical Technology & National Standard Bodies.
Agenda, Slides deck, Webinar Recording.
This policy series was followed by a webinar session from the U.S. FDA as part of the Coalition Regulator Series.
