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 8, 2020

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This event is FREE to attend

Join registration and listing staff in this workshop dedicated to assisting industry with creating complete and accurate registration and listing submissions. Ask questions to FDA subject matter experts.

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Keynote Speaker:

Paul Loebach
Director
Drug Registration and Listing Staff
Office of Program and Regulatory Operations
CDER | FDA

Paul Loebach

Topics Include:

  • Labeler Code Requests
  • Establishment Registration
  • Drug Listing
  • 503B Compounder Product Reporting using CDER Direct
  • Establishment Registration and Drug Listing Compliance Program

Download the Full Agenda

Who Should Attend?

  • Regulatory affairs professionals working on registration and listing submissions
  • U.S. Agents
  • Importers
  • Manufacturers, repackagers, relabelers, and private label distributors
  • Submission vendors

Continuing Education Credit

    This workshop:

  • has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.
  • has been 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.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
  • Real-time attendance is required for attendance certificates which are only available during the three weeks after the event.
Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 4, uploaded on September 16, 2019.

PDF Download
Speaker Biographies

This PDF file contains brief biographies of the FDA speakers participating in the conference.

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Virtual Attendance Information

The workshop will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted on the SBIA YouTube Channel within one week.

Room One will open 15 minutes before the event begins.

Please try Room One first.
Room Two will only be activated if Room One exceeds 1,000 participants.
Please do not join both rooms at the same time.

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, Certificate & Recordings

ZIP of the Workshop Slides

(The link above will be activated the day before the event)

Final Evaluation & Certificate of Attendance

(The link above will be activated at the end of the event)

Session recordings will be posted to
the SBIA YouTube Channel within one week.

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Questions & More Information

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: