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Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool

Track:
Pharmaceutical Quality

Day & Time:
June 19, 9:00AM - 10:30AM (Pacific Standard Time)

Session Number:
409

Room Number:
5A

Level:
Intermediate

Type:
Session

Title:
Question-Based Review (QbR): A Risk-Based, Standardized Pharmaceutical Quality Assessment Tool

Chair(s):
Jennifer A. Maguire, PhD
Acting Team Leader, Office of Pharmaceutical Science
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Question-Based Review: A Vision
Ramesh K. Sood, PhD
Deputy Office Director, Office of New Drug Quality Assessment, CDER
FDA, United States

Status Update on QbR for the Future Office Of Pharmaceutical Quality
Jennifer A. Maguire, PhD
Acting Team Leader, Office of Pharmaceutical Science
FDA, United States

QbR for ANDA: Effective Tool For Development, Submission, and Review
Sivakumar R Vaithiyalingam, PhD
Director, Regulatory Affairs
Teva Pharmaceuticals, United States

PhRMA’s Perspective on Risk-Based Regulatory Review
John Groskoph, MBA
Senior Director, Global CMC
Pfizer Inc, United States