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DIA Direct: Best Practices for In-Use Stability and Compatibility Studies

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Yasmin  de Faria Krim, PHARMD, MSC

Yasmin de Faria Krim, PHARMD, MSC

CMC working group , Chair, CMC Working Group, DIA Regulatory Affairs Community, France

Yasmin de Faria Krim is an active volunteer at DIA, as chairperson of the CMC working group within the DIA Regulatory Affairs Community. She was the program chair for four DIA CMC workshops in the US, co-sponsored by AAPS, one DIA CMC workshop in Europe, and has also chaired DIA webinars focusing on CMC topics. Yasmin has worked in Belgium, France, Switzerland and the UK, in CMC Regulatory Affairs and European Regulatory Affairs. Yasmin de Faria Krim holds a PharmD, a Master in Regulatory Affairs (International Drug Development and Registration), and a Master in Pharmaceutical Biotechnology and Advanced Therapies.

Katiria  Flores

Katiria Flores

Scientist III, Injectable Drug Product Development, Alexion Pharmaceuticals, Inc., United States

Katiria Flores, PhD, is a Senior Scientist in Injectable & Drug Product Development at AstraZeneca’s Alexion Rare Disease Unit. She has 7 years’ experience leading clinical in use compatibility studies, supporting IV and SC administration across 12+ Alexion products and multiple development phases. In addition to her experimental leadership, Dr. Flores plays a pivotal role on core cross functional teams, contributing to the review and approval of Instructions for Use (IFU), pharmacy manuals, and IND/BLA sections related to in use compatibility, ensuring rigor, regulatory alignment, and patient centric usability. She also serves on the IQ Consortium’s Physicochemical In Use Stability Testing Working Group.

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