Electronic Drug Registration and Listing
Using CDER Direct
October 22, 2019
Continuing Education Credit
- This one-day conference has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
- This event 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.
- ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
- SOCRA 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.
- Real-time attendance is required for attendance certificates which are only available during the two weeks after the event.
The agenda is subject to change. Updated versions will be linked here as they become available. The current version is 4, uploaded on October 9, 2019.
This PDF file contains brief biographies of the FDA speakers participating in the conference.
- Welcome from CDER’s Office of Compliance: Rosemary Cook
- Keynote from the Drug Registration and Listing Staff: Paul Loebach
- Establishment Registration and Labeler Code Requests: Don Duggan & Puii Huber
View Recording – View Q&A Recording
- NDC Reservation, Drug Listing, Compounded Product Reporting: Soo Jin Park, Troy Cu & David Mazyck
- Listing Certification and Inactivation: Leyla Rahjou Esfandiary & Regie Samuel
- Compliance Program and Case Study: Julian Chun & Tasneem Hussain
- DRLS Town Hall: DRLS Staff
If you have questions regarding the content of the event or other CDER-specific information, please: