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Quality Assessment and Submissions at FDA 2025 Banner

Knowledge Management and Modernization of Regulatory
Quality Assessment and Submissions at FDA
January 28-29, 2025

FDA’s Knowledge-aided Assessment and Structured Application (KASA) initiative is a creative regulatory approach for modernizing quality assessment and enhancing submission format. KASA is designed to capture and manage knowledge during the lifecycle of a drug product; establish rules and algorithms to facilitate risk identification, mitigation, and communication; perform computer-aided analyses of applications for a comparison of regulatory standards and quality risk across the repository of approved drug products and facilities; and provide a structured assessment that minimizes text-based narratives and summarization of information provided in applications.

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Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda is still being refined and may be updated over time. The current version is v4, uploaded on November 14, 2024.

PDF Download
Speaker Biographies

The speaker biographies document is under development and will be linked here when it is ready.

LOGIN Information

The links below will become active on the day of the workshop.

Login One

Attendance is tracked for CE.
Ability to submit questions, but cannot pause or rewind
1,000 seats – Use Login Two if this room is full

Login Two

Attendance is tracked for CE.
Ability to submit questions, Ability to pause or rewind
Unlimited Seating

Livestream Direct

Attendance IS NOT TRACKED for CE.
If you encounter issues with the above logins, us this link.

The above login rooms will open ~15 minutes before each day begins.

If you encounter any technical issues, visit the Technical Issues Support Page

The audio for the event will be provided through your computer speakers (there will NOT be a teleconference number to dial into).

Files & Recordings

Download Presentation Slides:

ZIP of the Day One Slides

ZIP of the Day Two Slides

The links above will become active on the day before the workshop begins.

Evaluation & Certificate:

Evaluation & Certificate of Attendance

The above link will become active near the close of the first day of the Workshop.

Session Recordings:

Recordings will be linked here as soon as they are available.

Questions & More Information

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 (until February 12, 2025).

This event 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.

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: