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Session 9: Medical Devices Regulatory Frameworks on the Move
Session Chair(s)
Roberta Mele Mazza, RPH, RAC
Q&RA Manager, División Diagnóstica
Productos Roche , Argentina
This session is a panel discussion intended to provide an overview of the new regulatory framework being discussed by Europe, FDA, and LATAM countries, from the perspectives of Health Authorities and Manufacturers. A discussion between health authorities and manufacturers’ clarifying what the needs are to implement the new approaches.
Learning Objective :
Upon completion of this session, the participant should be able to:
- Understand the new regulatory framework being discussed and implemented in different regions and analyze their impact in LATAM
- Have an overview of the challenges and analyze the new regulations nowadays being reviewed in LATAM and the different aspects of the point of views from Manufacturers and Health Authorities
Speaker(s)
Speaker
Natalia Rovira
EMD Serono, Inc, United States
Manager, Global Regulatory Affairs – Translational Medicine & Devices
Speaker
Mariela Aranda
ANMAT, Argentina
Head of IVD department