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Electronic Drug Registration and Listing (eDRLS) Using CDER Direct 2023 Banner

Electronic Drug Registration and Listing (eDRLS)
Using CDER Direct 2023
September 28, 2023

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This conference 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. FDA will provide:

  • A demonstration on how-to submit establishment registration and drug listing data using CDER Direct
  • An overview on registration and listing regulatory requirements and compliance framework
  • Case studies for an interactive learning experience at the end of the day

Click Here for Workshop Details

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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 v6, uploaded on August 28, 2023.

PDF Download
Speaker Biographies

The speaker biographies document provides detailed information for each of the event presenters.

LOGIN Information

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

Room One

Ability to submit questions, but cannot pause or rewind
1,000 seatsUse Room Two if this room is full

Room Two

Ability to pause or rewind, but cannot submit questions, download slides below
Unlimited Seating

The above rooms will open ~15 minutes before the webinar 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 via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files & Recordings

Download Presentation Slides:

ZIP of the Presentation Slides

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

Evaluation & Certificate:

Evaluation & Certificate of Attendance

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

Session Recordings:


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

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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 October 12, 2023).

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: