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FDA | Small Business and Industry Assistance (SBIA)
Advancing Generic Drug Development: Translating Science to Approval
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September 24-25, 2024 | 8:30 AM – 4:30 PM
In Person at The Bethesdan Hotel Bethesda, MD
KEYNOTE SPEAKER
Robert M. Califf M.D., MACC
Commissioner of Food and Drugs
Join us for the 2024 Advancing Generic Drug Development workshop. FDA experts will discuss and analyze the complex scientific issues encountered in generic drug development and abbreviated new drug applications (ANDAs). This workshop promises to be an invaluable opportunity to:
- Gain insights into GDUFA III updates and the latest scientific research on complex products
- Explore product-specific guidance development, pre-ANDA, and ANDA meeting discussions
- Discover innovative science and cutting-edge methodologies driving generic drug development
Attendees will engage with FDA scientists during a poster session, featuring topics such as:
- Research supporting guidance development
- Advanced analytical methods
- PBPK modeling
- Post-market surveillance
- ANDA assessment
- And more!
Don't miss this chance to connect with FDA experts and stay at the forefront of generic drug development. Register now!
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CONTINUING EDUCATION (CE)
This activity has been approved for 10.50 CE hours for physicians, pharmacists, and nurses. Real-time attendance is required and for further details, see the detailed announcement.
Real-time participation is required for the certificate of attendance which can be used in support of CEs for the following professional organizations: RAPS, SOCRA, SQA, and ACRP. Certificates are only available during the two weeks post-event. For more information, see details on our webpage.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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