About
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.
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
Intended Audience
- Regulatory affairs professionals (innovator and generic or biosimilar)
- Manufacturing professionals (domestic and foreign; drug product and API)
- Foreign regulators
- Healthcare professionals interested in learning more about the FDA’s drug quality functions
