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Location: Hybrid:

• In-Person at The Bethesdan Hotel, Tapestry Collection by Hilton, Bethesda, MD
• Virtual via Adobe Connect

Attend In Person or Online
Click HERE for Onsite Attendance Information Details

Agenda

Visit CDER Small Business and Industry Assistance Page

Keynote Speakers

ABOUT THIS EVENT

The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. The goal of the forum is to provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines.

This year’s theme is Regulatory Considerations to Enhance Generic Drug Access, and our agenda will address essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Presentations will focus on resources, best practices, common deficiencies, and opportunities to engage with the Agency from pre-ANDA to post-approval submissions.

INTENDED AUDIENCE

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

• Are involved in generic drug development
• Are submitting or have submitted a generic drug application, amendment, or supplement

TOPICS COVERED

• Controlled Correspondence
• Pre-ANDA Submissions and Meetings
• ANDA Submissions, Assessments, and Meetings
• Post-Approval Submissions
• Other Considerations

Agenda

FDA RESOURCES

• Product-Specific Guidances for Generic Drug Development
• Pharmaceutical Quality Resources
• Industry Resources
• Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
• Federal Register Notices Related to Generic Drugs
• GDUFA Science and Research
• Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book

CONTINUING EDUCATION

This event has been approved for a maximum of 13.25 contact hours of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. Registration and real-time attendance via Adobe Connect is required for CE eligibility.

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.
• 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.
• 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.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• 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
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.