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  4. Navigating Controlled Correspondences to Support Generic Drug Development - 02/27/2025
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Virtual | Virtual

Event Title
Navigating Controlled Correspondences to Support Generic Drug Development
February 27, 2025

Date:
February 27, 2025
Time:
1:00 p.m. - 3:30 p.m. ET

AGENDA

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ABOUT THIS EVENT (Hosted by CDER SBIA)

The FDA’s Office of Generic Drugs (OGD) plays a critical role in ensuring access to safe, effective, and affordable generic drugs. To facilitate the development and approval process, the FDA offers various pathways for communication, including controlled correspondence.

This event offers a comprehensive overview of controlled correspondence as an efficient pathway for communication with the FDA regarding generic drug development. FDA will host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA experts.

INTENDED AUDIENCE

This webinar is designed for generic drug developers and regulatory professionals looking to streamline their interactions with the FDA with the usage of Controlled Correspondence.

TOPICS

  • Navigating
    • formulation assessments
    • controlled correspondences related to bioequivalence approaches/studies
  • Clinical pharmacology topics in generic drug development
  • Role of controlled correspondences in supporting the safety evaluation of generic drugs

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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