miércoles, 16 de octubre de 2019

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

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

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 

No hay comentarios: