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Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective
Session Chair(s)
Moheb M. Nasr, PhD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
Three industry speakers, representing different segments of the pharma industry, will share their perspectives on Quality by Design (QbD) implementation progress. Presentations will outline different implementation approaches supplemented by case studies.
Learning Objective : Discuss the status of Quality by Design (QbD) implementation for industry perspectives; Discuss different implementation approaches; Identify remaining technical and regulatory challenges and make specific proposal to address current gaps; Describe proposed next steps to implement QbD.
Speaker(s)
Implementing QbD at a Major Pharmaceutical Company: Tales from the Road
Michael Thien, DrSc
Merck & Co., Inc., United States
Senior Vice President, Global Science, Technology and Commercialization
Lessons Learned From Implementing QbD for Two Novel Pharmaceutical Products: Progress Towards Global Regulatory Alignment
Patricia N. Hurter, PhD, MS
Vertex Pharmaceuticals, United States
Senior Vice President, CMC & Pre-Clinical Development
Lessons Learned From Two Case Studies in the FDA QbD Pilot for Biotech Products
Lynne Krummen, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Technical Regulatory, Biologics
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