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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)
Progress and Remaining Challenges: Industry Perspective
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
Progress and Remaining Challenges: FDA Perspective
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
EMA Perspective
Evdokia Korakianiti, PhD, MSc
European Medicines Agency, Netherlands
Head of Quality and Safety of Medicines
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