Sarah Pope Miksinski

Sarah Pope Miksinski

Company: AstraZeneca

Job title: Senior Director, Global Regulatory Affairs

Seminars:

Risk Benefit Considerations in Regulatory Applications 9:45 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 9:00 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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