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Session 2: Harmonization Initiatives and Best Practices
Session Chair(s)
Ana Padua, MSc, RPh
Director EU Global Regulatory and Scientific Policy
EMD Serono, Switzerland
This session will provide an overview of important initiatives related to the convergence and best practices among regulators in Mexico and Brazil. An industry perspective will be included to showcase experiences in reducing global regulatory complexities.
Speaker(s)
The Role of Frameworks in Building Quality into Regulatory Decisions
Justina Molzon, JD, MS
Consumer Services, United States
Consumer Services
ANVISA Application for ICH Observation
Balbiana V. Sampaio Oliveira, MS
ANVISA, Brazil
Advisor of Director - Pharmacist
Industry Perspective on Harmonization
Ivana R. Antonacci, MS
United States
Global Regulatory Consultant