Flavia C. Firmino

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Laboratorios Pfizer Ltda
Director
Flavia C. Firmino is the Regional Regulatory Advisor for the Latin America region in Global CMC at Pfizer since 2017. She holds accountability for partnering with manufacturing organization and regulatory affairs while providing regional regulatory expertise to CMC product strategists, addressing strategic issues, and contributing to the development of policies and positions on draft regulations in region and external engagement on CMC topics. She is based in Brazil. She has over 20 years of experience in pharmaceutical industry in quality and regulatory areas and held leadership positions in regulatory conformance, quality operations and regulatory affairs. Flavia holds a degree in pharmacy and biochemistry from the Oswaldo Cruz University in Brazil and a postgraduate degree in industrial administration. She has been a member of ISPE since 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...