Juliana Perlow

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MSD Brazil
Director, Regulatory Affairs-CMC
Juliana Perlow is currently Executive Director at MSD, where she leads the International CMC - Latin America team. In this role, Juliana is responsible for leading the regional strategy and execution of regional CMC postapproval variations and initial registration submissions for both small molecules and large molecules, including biologics and vaccines. A pharmacist with specialization in clinical pharmacology and project management, she also has an MBA. Juliana has more than 25 years of experience in pharmaceutical industries working in regional regulatory CMC and regulatory affairs functions. Ju-liana co-chairs the ISPE Latin America Regulatory Quality Harmonization Committee. She joined ISPE in 2019.

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This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and encourage open dialogue about harmonization, recognition agreements, and potential increase for export facilitation, all which...