287566 Panel Discussion (1hr slot)

Tuesday, October 30, 2012: 4:45 PM
Allegheny II (Westin )
Christopher L. Burcham, Eli Lilly and Company, Indianapolis, IN and Huiquan Wu, Division of Product Quality Research, HFD-940, FDA, Silver Spring, MD

Round Table Invited session on QbD: QbD filings As FDA continues to facilitate the modernization of regulatory processes related to pharmaceutical products in the 21st Century, Quality-by-Design (QbD) approaches for some of the pharmaceutical process/product development and manufacturing have been discussed intensively over the past few years in various forums. Some real-world case studies have been reported in the public literature. However, a risk-based and science-based approach for QbD filling based on the regulatory guidance and guidelines are barely shared and discussed in the public domain. As a first step, this round table discussion session is intended to address this information gap to the possible extent. Inputs from recognized experts and experienced practitioners in the community across academia, industry, and regulatory agencies in the world will be sought to identify commonality among QbD filing. An in-depth panel discussion following the presentations should stimulate innovative research and development in the QbD area, and facilitate the QbD implementation in the pharmaceutical sector.

The session chair/co-chair will lead the discussion. All of the invited speakers will be panelists. Active participation from the session attendees will be encouraged.


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