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Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool
Session Chair(s)
Jennifer A. Maguire, PHD
Division Director(Acting) Office of Surveillance, OPQ, FDA, United States
This session will focus on the implementation of Question-Based Review (QbR) in the future Office of Pharmaceutical Quality. The speakers will provide an update on the current state of QbR revisions and will discuss the initiatives affecting both new and generic drug applicants.
Learning Objective : Explain a brief history and update on FDA's Question-Based Review (QbR) tool; Discuss the implementation of revised QbR for the review of both new and generic drugs in the future Office of Pharmaceutical Quality; Discuss some of the revised QbR questions and the type of information sought from the applicant in response to the questions.
Speaker(s)
Ramesh K. Sood, PHD
Senior Scientific Advisor (Acting), Office of New Drug Products, CDER, FDA, United States
Question-Based Review: A Vision
Jennifer A. Maguire, PHD
Division Director(Acting) Office of Surveillance, OPQ, FDA, United States
Status Update on QbR for the Future Office Of Pharmaceutical Quality
Siva Vaithiyalingam, PHD
Sr. Vice President, Cipla LTD, United States
QbR for ANDA: Effective Tool For Development, Submission, and Review
John Groskoph, MBA
Executive Director, Global CMC, Pfizer Inc, United States
PhRMA’s Perspective on Risk-Based Regulatory Review
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