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.
The agenda may be updated as changes are made. The current version is Version 8, updated on October 12, 2021.
The speaker biographies document provides information about the event speakers.
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.
Links to recordings will be added here as they become available.
- 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.
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:
If you have questions regarding the content of the event or other CDER-specific information, please: