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 Generic Drugs Forum 2022:
The Current State of Generic Drugs
April 26-27, 2022
8:30 a.m. - 4:00 p.m. ET
Keynote
Sally Choe, Ph.D.
Director
Office of Generic Drugs (OGD)
CDER | FDA
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Keynote
Michael Kopcha, Ph.D., R.Ph.
Director
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
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- Data Integrity
- Facility Evaluations
- FDA’s Pre-ANDA Program
- Global Generic Drugs
- Knowledge-Aided Assessment and Structured Application (KASA)
- Overview of ANDA Program Statistics
- Pharmaceutical Quality Systems
- Post-Market Safety and Surveillance of Generic Drugs
- Product-Specific Guidances for Generic Drug Development
- Technical Considerations for Pharmaceutical Product Lifecycle Management
FDA Resources
- Product-Specific Guidances for Generic Drug Development
- Pharmaceutical Quality Resources
- Industry Resources
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Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
- Federal Register Notices Related to Generic Drugs
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Generic Drug User Fee Amendments (GDUFA) Science and Research
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Since 2013, the Generic Drugs Forum has been a way for FDA to offer practical advice, provide case studies, and take a deeper dive into the Abbreviated New Drug Application (ANDA) assessment process.
This year’s theme is The Current State of Generic Drugs and presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs.
AUDIENCE
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
- plan to submit, are in the process of submitting or have submitted an ANDA
- are involved in generic drug development
- work on generic drug bioequivalence, facility assessment, stability, dissolution and impurity testing
COST: This conference is FREE.
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