Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 4
Abstract
On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agencies, industry, and academia may exchange viewpoints and work together to advance pharmaceutical quality. This Conference Summary Report highlights key topics of this conference, including (1) risk-based approaches to pharmaceutical development, manufacturing, regulatory assessment, and post-approval changes; (2) FDA-proposed quality metrics for products, facilities, and quality management systems; (3) performance-based quality assessment and clinically relevant specifications; (4) recent developments and implementation of continuous manufacturing processes, question-based review, and European Medicines Agency (EMA)-FDA pilot for Quality-by-Design (QbD) applications; and (5) breakthrough therapies, biosimilars, and international harmonization, focusing on ICH M7 and Q3D guidelines. The second FDA/PQRI conference on advancing product quality is planned for October 5–7, 2015.
Authors and Affiliations
Lawrence X. Yu, Jeffrey Baker, Susan C. Berlam, Ashley Boam, E. J. Brandreth, Lucinda Buhse, Thomas Cosgrove, David Doleski, Lynne Ensor, Joseph Famulare, Mohan Ganapathy, Gustavo Grampp, David Hussong, Robert Iser, Gordon Johnston, Filippos Kesisoglou, Mansoor Khan, Steven Kozlowski, Emanuela Lacana, Sau L. Lee, Stephen Miller, Sarah Pope Miksinski, Christine M. V. Moore, Theresa Mullin, G. K. Raju, Andre Raw, Susan Rosencrance, Mark Rosolowsky, Paul Stinavage, Hayden Thomas, Russell Wesdyk, Joerg Windisch, Sivakumar Vaithiyalingam
Keywords
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