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Session 2: Reliance and Regulatory Systems Strengthening
Session Chair(s)
Cammilla Horta Gomes, MA, MPHARM
Latam Regulatory Policy Lead , Roche, Brazil
This session will provide an overview of the most recent developments in the area of reliance and regulatory systems strengthening, with a focus on PAHO activities, the industry perspective and experiences from regulators in the LATAM region. Each presenter will have approximately 10-15 minutes to provide a presentation. At the end, there will be a 20-minute Q&A panel with the participation of all speakers.
Learning Objective :
Upon completion of this session, the participant should be able to:
- Recognize current and planned regional activities in the area of reliance and regulatory systems strengthening
- Understand PAHO’s concept note with principles for regulatory reliance
- Be familiar with the Central American Joint Evaluation Mechanism for the registration of medicines
- Understand the industry point of view on reliance and regulatory systems strengthening
Speaker(s)
PANDRH’s Concept Note on Regulatory Reliance Principles
Health Regulatory Systems, Consultant, Switzerland
Regulatory Reliance and its Role in Regulatory System Strengthening An Industry Perspective
Head of Regulatory Science & Policy EU/AMEE, Sanofi, United Kingdom
Speaker
Advisor, Regulatory System Strengthening for Medicines & Other Health Technology, Pan American Health Organization (PAHO), United States
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