Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
Journal Title: The AAPS Journal - Year 2016, Vol 18, Issue 2
Abstract
The purpose of the Conference on Advancing Product Quality, under the sponsorship of the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI), is to bring regulators, industry professionals, and academic researchers together to create a synergized path toward enhanced global pharmaceutical quality. The 2015 FDA/PQRI Conference consisted of a plenary session and 20 breakout sessions arranged in four major tracks: (i) emerging regulatory initiatives; (ii) regulatory submission, assessment, and inspection; (iii) product and process development; and (iv) manufacturing, risk management, and quality assurance. This report provides a summary of the plenary session followed by each topic, as presented at the conference.
Authors and Affiliations
Lawrence X. Yu, Ilgaz Akseli, Barbara Allen, Gregory Amidon, Tara Gooen Bizjak, Ashley Boam, Margaret Caulk, David Doleski, Joseph Famulare, Adam C. Fisher, Scott Furness, Brian Hasselbalch, Henry Havel, Stephen W. Hoag, Robert Iser, Bruce D. Johnson, Robert Ju, Paula Katz, Emanuela Lacana, Sau L. Lee, Richard Lostritto, Grace McNally, Mehul Mehta, Ganapathy Mohan, Moheb Nasr, Roger Nosal, Mary Oates, Thomas O’Connor, Jim Polli, G. K. Raju, Mahesh Ramanadham, Giuseppe Randazzo, Susan Rosencrance, Anna Schwendeman, Arzu Selen, Paul Seo, Vinod Shah, Ramesh Sood, Michael P. Thien, Tony Tong, Bernhardt L. Trout, Katherine Tyner, Siva Vaithiyalingam, Martin VanTrieste, Fionnuala Walsh, Russell Wesdyk, Janet Woodcock, Geoffrey Wu, Larisa Wu, Louis Yu, Diane Zezza
Keywords
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