Principal Scientist
US Pharmacopeia
Rockville, Maryland
Naiffer has more than 20+ years of pharmaceutical industry experience. In his 15 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with national regulatory bodies.
Naiffer's journey with USP continued in 2020 when he joined the Scientific Affair. Here, he leads scientific outreach and technical engagement on critical national health priority topics. His broad pharmaceutical expertise encompasses Analytical development, salt and polymorph selection, Development of dissolution methods, IVIVC modeling, and impurity analytical strategy. However, his true passion lies in nitrosamine impurities, where he is a recognized subject matter expert with several publications. He also plays a crucial role as a member of USP’s Nitrosamine workstream Committee and as a community manager for ‘Nitrosamine Exchange’, a knowledge community hosted by USP for All-things Nitrosamines Impurities.
Naiffer also liaises technical discussions on pharmacopeial collaboration, including the International Meeting of World Pharmacopeias (part of WHO) and international compendial discussion groups (PDG), and is a member of several regional regulatory agencies’ nitrosamines working groups. Naiffer recently joined the recently formed ICH M7 subgroup in charge of the revision of the international guideline.
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Risk in Pharmaceutical Quality: Role of the Documentary and Reference Standard. Case Studies.
Tuesday, October 22, 2024
9:30 AM – 10:30 AM MT