Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

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