Electronic Drug Registration and Listing
Using CDER Direct
October 8, 2020
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.
Continuing Education Credit
- 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.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 5, uploaded on October 5, 2019.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
- Keynote: eDRLS and the COVID-19 National Health Emergency
- Session 1: Labeler Code Request
- Session 2: Establishment Registration
- Session 3: Drug Listing
- Session 4: 503B Compounder Product Reporting using CDER Direct
- Session 5: Establishment Registration and Drug Listing Compliance Program
If you have questions regarding the content of the event or other CDER-specific information, please: