- Date:
- March 13, 2025
- Time:
- 1:00 p.m. - 3:00 p.m. ET
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ABOUT THIS EVENT (Hosted by CDER SBIA)
This event will provide an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned.
Following the presentations, FDA staff will engage in a panel discussion in addition to a Q&A session.
INTENDED AUDIENCE
This webinar is designed for members of the generic drug industry, including:
- Current and potential holders and applicants of abbreviated new drug applications (ANDAs) who are interested in using modeling and simulation to support their applications
- Prospective drug master file (DMF) holders
- Regulatory reviewers for generic drug development and assessments
- Industry consultants focused on bioequivalence approaches
- Clinical research coordinators and foreign regulators
LEARNING OBJECTIVES
- Describe the purpose, benefits, and challenges of MMFs
- Understand how to navigate the process for using the Type V DMF for MMF submissions to support ANDAs
- Recognize the value MMFs provide to the development, assessment, and approval of high-quality generic drugs
- Implement best practices for MMF submissions in your work
SPEAKERS and PANELISTS (see AGENDA)
FDA RESOURCES
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.
- 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
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