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Session 3: Update on IMDRF and MDSAP and Their Relevance to the Latin America Region
Session Chair(s)
Ana Pineda Zavaleta, MSc
International Regulatory Analyst, LAO, OGPS, OPLIA, OC
FDA, United States
This session is intended to raise awareness in the IMDRF activities and how the medical devices regulators and stakeholders in the Latin America region could benefit from the guidelines and convergence activities, such as the MDSAP.
Learning Objective : At the conclusion of this session, participants should be able to:- Outline the goals of the IMDRF and the benefits from engaging in IMDRF activities
- Describe the fundamental guidelines and working groups of the IMDRF
- Explore ways to benefit from the information generated by the MDSAP
- Obtain greater understanding of the IMDRF accession process and requirements
Speaker(s)
MDSAP Overview
Nancy Shadeed
Health Canada, Canada
Manager, International Affairs Division, Therapeutic Products Directorate
Speaker
Melissa Torres, MS
FDA, United States
Associate Director for International Affairs, CDRH
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