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Agenda

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KEYNOTE SPEAKERS

 

ABOUT THIS EVENT

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice, presenting case studies, and taking a deep 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.

TOPICS COVERED

• Data Integrity
• Facility Evaluation
• 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

INTENDED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

• plan to submit an ANDA, are in the process of submitting an ANDA or have submitted an ANDA
• involved in generic drug development
• work on generic drug bioequivalence, facility evaluation, stability, dissolution and impurity testing

FDA RESOURCES

1. Product-Specific Guidances for Generic Drug Development
2. Pharmaceutical Quality Resources
3. Industry Resources
4. Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
5. Federal Register Notices Related to Generic Drugs
6. Generic Drug User Fee Amendments (GDUFA) Science and Research

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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• Please contact [email protected] for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
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