Sarah Pope Miksinski

Sarah Pope Miksinski

Company: AstraZeneca

Job title: Senior Director, Global Regulatory Affairs

Bio:

Sarah Pope Miksinski is a Senior Director in Global Medicines Development, Global Regulatory Affairs, Patient Safety, and Quality Assurance at AstraZeneca. She was appointed to the position in 2018 and serves as a recognized subject matter expert on the current CMC regulatory environment. Prior to her role with AstraZeneca, Sarah spent nearly 16 years at the FDA where she started as a review chemist and held several subsequent positions before serving as Office Director in the Office of New Drug Products and Office Director (acting) in the Office of Surveillance. In recognition for her work at FDA, Sarah received the 2014 Leadership in Action Award by the Partnership for Public Service. Additionally, Sarah has authored over 10 industry publications and is considered a thought leader in the regulatory arena. Sarah has been a member of ISPE Since 2018. She holds a Ph.D. in organic chemistry from Oklahoma State University and a Bachelor’s degree in chemistry/biology from Earlham College.

Seminars:

Risk Benefit Considerations in Regulatory Applications 8:45 am

• Bridging the gap between case-by-case approach and predicting what regulators need • With multiple considerations, continuous validation, real time release testing ect. how to prioritize and communicate in global dossier preparation • Balancing the data with the story: Seeing the big picture to translate technical data into concise, quality control strategyRead more

day: Day Two

Panel Discussion: Measure Vs Model in CM Validation & Approval 9:45 am

• What measurements can be replaced with a model, whilst retaining product quality and regulatory compliance? • How can regulatory approval for CM differ across the world? • Key differences between traditional bath processing vs continuous in regulatory submission, e.g. continuous process validation • Inspection preparedness as we move into commercial spaceRead more

day: Day Two

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