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Session 2 Follow Up: The Evaluation of National Regulatory Authorities as Tool for Strengthening Regulatory Systems in the Americas
Session Chair(s)
Susan Zavala Coloma, MS, RPh
Specialist, Sanitary Evaluation of Pharmaceutical Products, Biological Products
DIGEMID, Peru
Cammilla Horta Gomes, MA, MPharm
LATAM Regulatory Policy Lead
Roche, Brazil
For more than a decade, the Pan American Health Organization (PAHO) has been implementing a regional system for evaluation of National Regulatory Authorities (NRAs) for medicines. This process of evaluation and assessment of NRAs is based on verification of the indicators included in a regionally developed data collection tool, which was based on recommendations from the World Health Organization (WHO). This system has been used to define NRAs of regional reference in the Americas – currently ANMAT, ANVISA, CECMED, COFEPRIS, Health Canada, INVIMA, ISP, and US FDA. The regional data collection tool was the main source used by WHO to create its Global Benchmarking Tool (GBT). This short session aims at providing insights, from PAHO’s perspective, on the future of the assessment of NRAs in the Americas, and how the concept of NRA of regional reference will dialogue with the framework for designating and publicly listing WHO-listed authority (WLA).
Learning Objective : At the conclusion of this session, participants should be able to:- Distinguish the concepts of NRAs of regional reference and of WHO Listed Authorities
- Assess the relevance and purpose of the designation of reference authorities, including in the implementation of reliance
- Identify the roles and responsibilities of reference authorities in the context of the ongoing efforts in strengthening regulatory systems in the Americas
Speaker(s)
Speaker
Susan Zavala Coloma, MS, RPh
DIGEMID, Peru
Specialist, Sanitary Evaluation of Pharmaceutical Products, Biological Products
Speaker
Cammilla Horta Gomes, MA, MPharm
Roche, Brazil
LATAM Regulatory Policy Lead
Interviewee
Analia Porras
Pan American Health Organization (PAHO), United States
Unit Chief, Medicines and Health Technologies
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