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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, Regulatory Policy for Emerging Markets -Japan and Australia
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)
Moderators
Pedro Franco, PharmD, PhD, MS, MSc
Merck Serono Limited, United Kingdom
Senior Director for Global Regulatory & Scientific Policy (GRASP)
Moderator
Maria Cristina Mota Pina, MBA
AbbVie, United States
Head, Regulatory Policy for Emerging Markets -Japan and Australia
Panelists
Representative Invited
ANMAT, Argentina
Panelists
Leonardo Dutra Rosa
ANVISA, Brazil
Head of the International Affairs Office
Panelists
Heriberto Enrique García Escorza, MPA, RPh
Instituto de Salud Pública de Chile, Chile
Director
Panelists
Olga Lidia Jacobo Casanueva
CECMED, Cayman Islands
Director
Panelists
Celia Lourenco, PhD
Health Canada, Canada
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
Panelists
Katherine Marie Serrano
FDA, United States
Director, Europe Office, Office of Global Policy and Strategy
Speaker
Miriam Jackeline Jackeline Loera Rosales
COFEPRIS, Mexico
Commissioner of Evidence and Risk Management
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