1. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference
- Author
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Andre Raw, Filippos Kesisoglou, Lucinda F. Buhse, Russell Wesdyk, Sarah Pope Miksinski, E. J. Brandreth, Stephen P. F. Miller, Jeffrey Baker, Ashley Boam, Susan Rosencrance, Mohan Ganapathy, Sau L. Lee, Christine M. V. Moore, Gustavo Grampp, Robert Iser, Thomas Cosgrove, Gordon Johnston, Hayden Thomas, Paul Stinavage, David Doleski, Steven Kozlowski, Joerg Windisch, Emanuela Lacana, Lawrence X. Yu, Joseph Famulare, David Hussong, G. K. Raju, Mark Rosolowsky, S R Vaithiyalingam, Mansoor A. Khan, Susan C. Berlam, Lynne Ensor, and Theresa Mullin
- Subjects
Management science ,business.industry ,media_common.quotation_subject ,Pharmaceutical Science ,Biosimilar ,Pharmacy ,Continuous manufacturing ,Meeting Report ,Viewpoints ,Engineering management ,Quality management system ,Agency (sociology) ,Quality (business) ,Business ,Product (category theory) ,media_common - 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.
- Published
- 2015