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2022 ISPE Annual Meeting & Expo

SES208b - ICH Q12 Implementation for Synthetic Drugs in Brazil – Status and Next Steps

Nov 1, 2022 1:45pm ‐ Nov 1, 2022 3:15pm


Raphael will present an overview on first steps of ICH Q12 implementation in Brazil, including RDC 690/2022 (PACMP implementation for small molecules), and the challenges for implementation of all ICH Q12 concepts and tools in the Brazilian regulatory framework.


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