SBIA Education Events

Supporting Events from FDA CDER Small Business & Industry Assistance

2020 Electronic Drug Registration and Listing Using CDER Direct Header Banner

Electronic Drug Registration and Listing
Using CDER Direct
October 13, 2021

This conference is part of the SBIA Regulatory Education for Industry (REdI) series and is intended to provide basic instruction in the registration and listing policy and process for those who are new to this regulatory program as well as offer regulatory professionals more in-depth information on issues and current events affecting Drug Registration and Listing.


Agenda & Speaker Bios

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Event Agenda

The agenda may be updated as changes are made. The current version is Version 8, updated on October 12, 2021.

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Speaker Biographies

The speaker biographies document provides information about the event speakers.

Files, Certificate & Recordings

Final Evaluation & Certificate of Attendance

NOTE: The link to download the certificate will be shown upon completion of the evaluation.
The evaluation and certificate are only available until October 27, 2021.

Session Recordings:

Links to recordings will be added here as they become 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.

    This workshop 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.

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: