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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
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)
Question-Based Review: A Vision
Ramesh K. Sood, PhD
FDA, United States
Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
Status Update on QbR for the Future Office Of Pharmaceutical Quality
Jennifer A. Maguire, PhD
FDA, United States
Division Director(Acting) Office of Surveillance
QbR for ANDA: Effective Tool For Development, Submission, and Review
Sivakumar R Vaithiyalingam, PhD
ARK Pharma Services LLC, United States
Principal
PhRMA’s Perspective on Risk-Based Regulatory Review
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
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