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Session 9: A Conversation with the Regulatory Authorities of Regional Reference of the Americas and Closing Remarks
Session Chair(s)
Maria Cristina Mota Pina, MBA
Head of Intercontinental Regulatory Policy & Intelligence, AbbVie, United States
Pedro Franco, PHARMD, PHD, MS, MSC
Senior Director for Global Regulatory & Scientific Policy (GRASP), Merck Serono Limited, United Kingdom
To support regional cooperation, as well as to promote concepts such as regulatory convergence and reliance, the Pan American Health Organization (PAHO) introduced the concept of National Regulatory Authorities of Regional Reference (NRArr). Currently, based on the criteria of a qualification system developed by PAHO, six regulators in Latin America are classified as NRArr, ANMAT, ANVISA, COFEPRIS, CECMED, INVIMA and ISP. Together with the US FDA and Health Canada, these regulators represent the most mature regulatory systems in the region. These regulators are committed to enhance not only their national regulatory practices and procedures, but also to support other regulatory systems in the region in becoming stronger. This panel-style session will represent a guided conversation with key representatives from these NRArr, as an opportunity to further understand their trajectory, lessons learned, current challenges, upcoming plans, and expectations for regional and international cooperation.
Learning Objective : - Recognize the responsibilities of regulators in improving access to safe, efficacious, and quality medical products, and their role in the region
- Distinguish main actions and best practices implemented by the NRArr from Latin America in the past year and lessons learned from COVID-19
- Identify current and future regulatory projects and priorities from regulators, including regional and international initiatives
Speaker(s)
Pedro Franco, PHARMD, PHD, MS, MSC
Senior Director for Global Regulatory & Scientific Policy (GRASP), Merck Serono Limited, United Kingdom
Maria Cristina Mota Pina, MBA
Head of Intercontinental Regulatory Policy & Intelligence, AbbVie, United States
Panelists
Representative Invited
Director of Institutional Relations, ANMAT, Argentina
Leonardo Dutra Rosa
Head of the International Affairs Office, ANVISA, Brazil
Heriberto Enrique García Escorza, MPA, RPH
Director, Instituto de Salud Pública de Chile, Chile
Olga Lidia Jacobo Casanueva
Director, CECMED, Cayman Islands
Celia Lourenco, PHD
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
Katherine Marie Serrano
Director, Europe Office, Office of Global Policy and Strategy, FDA, United States
Miriam Jackeline Jackeline Loera Rosales
Commissioner of Evidence and Risk Management, COFEPRIS, Mexico
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