CDER SBIA | Pharmaceutical Quality Symposium – Oct. 16-17, 2019

Pharmaceutical Quality Symposium Oct. 16-17, 2019 | College Park, MD

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FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency. In this era of globalization, engaging stakeholders is essential to furthering the overall commitment to pharmaceutical quality. FDA’s goal for this event is to share information and emphasize the critical role quality plays in assuring the safety and efficacy of pharmaceutical products.  We look forward to discussing this commitment to quality with you at this symposium.

Agenda

Keynote FDA Speakers Patrizia Cavazzoni, MD Deputy Center Director for Operations Center for Drug Evaluation and Research (CDER) | FDA Michael Kopcha, PhD, RPh Director Office of Pharmaceutical Quality (OPQ) | CDER | FDA

Topics Covered Manufacturing and the Quality Assessment of Applications Quality Beyond Application Approval Emerging Technologies in Pharmaceutical Manufacturing and Design Happenings in Biologics: Biosimilars and Transition Biological Products