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Session 1: Accelerated Programs
Session Chair(s)
Silke Klick, PHD
Regulatory Director CMC
AstraZeneca, Sweden
This session will give an overview of accelerated programs in a global regulatory environment. Challenges in the CMC area will be illustrated by case studies, providing both industry and regulator perspective.
Speaker(s)
Expedited Programs – Implications and Innovations in Quality Assessment
Sarah Pope Miksinski, PHD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Manufacturing Challenges and Opportunities for Accelerated Development Programs
Earl S. Dye, PHD
Genentech, A Member of the Roche Group, United States
Director, Technical Regulatory Policy
Accelerated Programs – Experiences from a Small Molecule NME Global Roll-Out
Silke Klick, PHD
AstraZeneca, Sweden
Regulatory Director CMC