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Session Chair(s)
Moheb M. Nasr, PHD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
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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