戻る Agenda
Implementation of Quality by Design: Progress, Challenges and Opportunities - FDA Perspective
Session Chair(s)
Christine Moore, PHD
Executive Director, Global External Advocacy and Standards
Organon & Co., United States
This session will describe the implementation of Quality by Design (QbD) in FDA's Center for Drug Evaluation (CDER). Opportunities will be discussed for application of QbD approaches to support continuous improvement and assurance of product quality.
Learning Objective : Explain how CDER is integrating Quality by Design (QbD) approaches into application review for NDAs, ANDAs and BLAs; Identify the various FDA pilot programs and initiatives for implementation of QbD.
Speaker(s)
Panelist
Sarah Pope Miksinski, PHD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Panelist
Susan Rosencrance, PHD
FDA, United States
Acting Director, Office of Generic Drugs, CDER
Panelist
Laurie Graham
FDA, United States
Director, DIPAP, OPPQ, OPQ, CDER