Session 3 – Regulatory convergence and Collaboration
During this session, representatives of global regulatory bodies, industry, and academia who are directly involved in the management of the regulatory process exchanged knowledge and experiences on the evolving regulatory environment of medical products regarding initiatives of convergence, both regional and international agencies, and understand how it helps streamline the regulatory process to facilitate the achievement of public health goals.
Dr. Larry Liberty – Adjunct Assistant Professor, Temple University School of Pharmacy (USA)
Martin Harvey – EMA – Head of International Affairs at European Medicines Agency (Netherlands)
Gustavo Mendes Lima – General Manager of Medicines & Biological Products ANVISA (Brazil)
Heriberto Garcia – Public Health Institute Director (Chile)
Miriam Jacqueline Loera, Director International Affairs, COFEPRIS (Mexico)
Angelika Joos – International Federation of Pharmaceutical Manufacturers & Associations IFPMA (Belgium)
Sandra Ligia González – Inter-American Coalition for Regulatory Convergence of the Medical Technology (Mexico) Presentation Talking Points
August 19, 2021
ILAR
Webinar Regulatory strengthening en Latin America in times of COVID-19 and its impact in Self-care, organized by Asociación Latinoamericana de Autocuidado Responsable
COVID-19 pandemic has highlighted the importance of strategies to strengthen the regulatory systems in Latin America, intended to warrant safety, quality and efficacy of medicines and other self-care products. This event will gather recognized experts in the region to share on their reflections on those strategies.
Panel Invitees:
Dr. Samvel Azatyan, World Health Orgaanization (WHO) – Good Reliance Practices – Presentation
Dr. José Vicente Coto, Panamerican Health Organization (PAHO) – Mecanisms for a Joint Evaluation of Dossiers of Medicines in Central America – Presentation only available in Spanish
Cristina Mota Pina, Federación Latinoamericana de la Industria Farmacéutica (FIFARMA) – Regulatory strengthening in Latin America in times of COVID-19 and its impact in Self-care – Presentation only available in Spanish
Sandra Ligia González, Representante de la Inter-American Coalition for Regulatory Convergence, Medical Technology Sector – Regulatory strengthening in Latin America in times of COVID-19 and its impact in Self-care- Presentation only available in Spanish
Original Recording
June 11, 2020
UNIDO
Trade, Quality and Safety of Health Products in the time of COVID: What lessons so far?
Webinar materials are available by clicking the following links:
Webcast recording (Password: 8K?g.?NS)
ANVISA – The Perspective of Brazil
Challenges of meeting standards and conformity assessment in the times of Covid-Indian industry experience
Quality and Safety of Products in the Time of COVID-19. What lessons so far?
February 25, 2020
WTO/TBT
Thematic session on Good Regulatory Practices examining the impact on the sectors of medical devices and new vehicle technologies. The medical device session included presentations from the FDA, Health Canada, the Coalition, the EU and Japan. Session, Slides Deck, Talking Points and Video Webcast. The table below shows the time at the recording where you can listen to specific presentations:
FDA
0:08:00-0:16:00
Health Canada
0:16:00-0:31:00
Inter-American Coaliton for Regulatory Convergence