Flavia Firmino

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Laboratorios Pfizer Ltda
Director
Flávia C. Firmino is Director of the Global CMC at Pfizer, with the role of Regulatory Advisor for Latin America and Africa/Middle East. In this role, she provides guidance and direction to project teams to mitigate regulatory risk and integrate CMC policy with product strategies, while developing and advocating policy positions on draft regulations on CMC topics. She is based in Brazil and has over 20 years of experience in pharmaceutical industry quality and regulatory areas. She has held leadership positions in regulatory conformance, quality operations, and regulatory affairs. Flávia co-chairs the ISPE Latin America Regulatory Quality Harmonization Committee, is a member of the ISPE Regulatory Steering Committee, and is the IFPMA’s ICH Management Committee delegate. Flávia graduated as a pharmacist at Oswaldo Cruz Foundation in Brazil and has a postgraduate degree in industrial administration. She joined ISPE in 2014.

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CMC Requirements for New Drug Registration in Latin America
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CMC Requirements for New Drug Registration in Latin America

The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. This article offers an overview of the chemistry, manufacturing, and controls...