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Implementation of Quality by Design: Progress Update
Session Chair(s)
Moheb M. Nasr, PHD, MS
Principal, Nasr Pharma Regulatory Consulting, United States
Leading industry and regulatory speakers will share their perspectives on quality by design (QbD) implementation progress. The session will outline specific implementation strategies and progress made so far, as well as remaining regulatory and technical challenges.
Learning Objective : Discuss the current state of implementation of quality by design (QbD) in the US; Describe different implementation approaches; Outline remaining technical and regulatory challenges; Make specific proposals to address identified challenges; Identify challenges of current approaches based on their own experience.
Speaker(s)
John Groskoph, MBA
Executive Director, Global CMC, Pfizer Inc, United States
Progress and Remaining Challenges: Industry Perspective
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Progress and Remaining Challenges: FDA Perspective
Evdokia Korakianiti, PHD, MSC
Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
EMA Perspective
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