%0 Journal Article
%T Advancing Product Quality: a Summary of the Second FDA/PQRI Conference
%A Adam C. Fisher
%A Anna Schwendeman
%A Arzu Selen
%A Ashley Boam
%A Barbara Allen
%A Bernhardt L. Trout
%A Brian Hasselbalch
%A Bruce D. Johnson
%A David Doleski
%A Diane Zezza
%A Emanuela Lacana
%A Fionnuala Walsh
%A G. K. Raju
%A Ganapathy Mohan
%A Geoffrey Wu
%A Giuseppe Randazzo
%A Grace McNally
%A Gregory Amidon
%A Henry Havel
%A Ilgaz Akseli
%A Janet Woodcock
%A Jim Polli
%A Joseph Famulare
%A Katherine Tyner
%A Larisa Wu
%A Lawrence X. Yu
%A Louis Yu
%A Mahesh Ramanadham
%A Margaret Caulk
%A Martin VanTrieste
%A Mary Oates
%A Mehul Mehta
%A Michael P. Thien
%A Moheb Nasr
%A Paul Seo
%A Paula Katz
%A Ramesh Sood
%A Richard Lostritto
%A Robert Iser
%A Robert Ju
%A Roger Nosal
%A Russell Wesdyk
%A Sau L. Lee
%A Scott Furness
%A Siva Vaithiyalingam
%A Stephen W. Hoag
%A Susan Rosencrance
%A Tara Gooen Bizjak
%A Thomas O¡¯Connor
%A Tony Tong
%A Vinod Shah
%J Archive of "The AAPS Journal".
%D 2016
%R 10.1208/s12248-016-9874-5
%X 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
%U https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4779106/