Webcast | Virtual
Event Title
Regulatory Education for Industry: Drug Registration and Listing Workshop
October 8, 2020
- Date:
- October 8, 2020
- Time:
- 9:00 AM - 5:00 PM ET
Labeler Code Request
|
Don Duggan |
Establishment Registration
|
Regie Samuel |
Drug Listing
|
David Mazyck |
503B Compounder Product Reporting using CDER Direct
|
Soo Jin Park
|
Establishment Registration and Drug Listing Compliance Program
|
Julian Chun |
ABOUT
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.
INTENDED AUDIENCE
- Regulatory affairs professionals working on registration and listing submissions
- U.S. Agents
- Importers
- Manufacturers, repackagers, relabelers, and private label distributers
- Submission vendors
TOPICS COVERED
- Labeler Code Requests
- Establishment Registration
- Drug Listing
- 503B Compounder Product Reporting using CDER Direct
- Establishment Registration and Drug Listing Compliance Program
- All sessions include a Q&A panel
FDA RESOURCES
- Drug Registration and Listing
- Structured Product Labeling
- NDC Directory
- Drug Establishments Current Registration
CONTINUING EDUCATION
Real-time attendance is required for the certificate of attendance. Certificates are only available during the three weeks post-event. This course:
- has been pre-approved by RAPS as eligible for up to 12 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.
Event Materials
Title | File Type/Size |
---|---|
eDRLS-2020-Agenda.pdf | pdf (219.04 KB) |