Webcast TODAY: CDER SBIA Pharmaceutical Quality Symposium Oct 16-17, 2019

CDER Small Business and Industry Assistance (SBIA) Pharmaceutical Quality Symposium Webcast Today and Tomorrow FREE | 8:30 a.m. - 4:30 p.m. Eastern

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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.

Wednesday, October 16 The Quality Assessment of Different Application Types Application Manufacturing Assessment  Policy Initiatives for Pharmaceutical Quality  How Does FDA Execute Preapproval and Postapproval Inspections?  Integration of Assessment and Inspection: Small Molecule Case Studies  Integration of Assessment and Inspection: Biological Products Case Studies  The Future of FDA’s Quality Assessment and Knowledge Management  Postapproval Change Management: ICH Q12 and Established Conditions  Pharmaceutical Quality Surveillance Program  Quality-Related Enforcement Actions and Trends  The Importance of Quality Metrics and Quality Culture  Thursday, October 17 Interacting with CDER’s Emerging Technology Program  Policy Considerations for Continuous Manufacturing  Continuous Manufacturing of Drug Product: Case Studies  Continuous Manufacturing of Drug Substance: Case Studies  Emerging Technologies for Biologics: Multi-Attribute Method  FDA Research Supporting Emerging Technologies with Case Studies  Extramural Research Supporting Emerging Technologies  FDA’s Biosimilars Program  Biosimilars Manufacturing Issues with Case Studies  Data Quality Expectations for Biosimilars with Case Studies  The “Deemed to be a License” Provision of the BPCI Act  Quality Considerations for Transition Biological Products