bstÁculos TÉcnicos al Comercio
Thematic session on Good Regulatory Practice
Encouraging regulatory compatibility and cooperation
At the Eighth Triennial Review, Members agreed to continue to hold thematic sessions in conjunction with its regular meetings during 2019 to 2021, with a view to further deepening the Committee's exchange of experiences on specific topics, and to hold a session on good regulatory practice (GRP) in February 2020 with a focus on: Encouraging regulatory compatibility and cooperation.
Moderator: Ms Renata Cristaldo (Paraguay)
Panel 1: Medical devices
- United States: Examples of Regulatory Cooperation in the Medical Device Sector: The International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP), Ms. Melissa Torres, Associate Director for International Affairs, Office of the Center Director, Center for Devices and Radiological Health, US Food and Drug Administration.
Presentation - Canada: Canada's Experience in Regulatory Cooperation in the Medical Devices Sector, Ms. Nancy Shadeed, Manager, International Programs Division, Office of Policy and International Programs, Medical Device Directorate, Health Canada.
Presentation - United States: Good Regulatory Practices, Technical Barriers to Trade and the Impact for the Medical Technology Sector, Ms Renata Amaral, Visiting Scholar - American University Washington College of Law, Technical Secretariat – Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector.
Presentation - European Union: Efforts to support global regulatory convergence in the field of medical devices and mechanisms for exchange of post market safety information on medical devices with global distribution, Mr. Erik Hansson, Deputy Head of Unit, Medical Devices, Directorate-General for Health and Food Safety (SANTE), European Commission.
Presentation - Japan: Regulatory Cooperation on Medical Devices, Mr. Minoru Iijima, Deputy Director for International Trade division, Economic Affairs Bureau, Ministry of Foreign Affairs of Japan, (on behalf of Ministry of Health, Labour and Welfare, Japan).
Presentation
Panel 2: New vehicle technologies
- European Union: UNECE World Forum for the harmonization of vehicle regulations – a global standard bearer and blueprint for EU legislation, Ms Ivone Kaizeler, Team Leader, Automotive and Mobility Industries, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (GROW), European Commission.
Presentation - Japan: Japanese Policy and contribution to the International Activities on Automated Driving, Mr. Kensuke Suzuki, Deputy Director for Road Transport Policy Planning, General Affairs Division, Ministry of Land, Infrastructure, Transport and Tourism of Japan.
Presentation