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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)
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Expedited Programs – Implications and Innovations in Quality Assessment
Earl S. Dye, PHD
Director, Technical Regulatory Policy , Genentech, A Member of the Roche Group, United States
Manufacturing Challenges and Opportunities for Accelerated Development Programs
Silke Klick, PHD
Regulatory Director CMC, AstraZeneca, Sweden
Accelerated Programs – Experiences from a Small Molecule NME Global Roll-Out
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