- June 22, 2022
- 1:00 PM - 3:30 PM ET
- Organized By:
On June 22, 2022, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) will host a live webinar titled, “Reporting of Veterinary Drug Supply Chain Information Using the Animal Drug Manufacturing System (ADMS) eSubmitter Tool.” The eSubmitter tool is a free software used to support the creation of electronic, secure submissions to CVM for review. The webinar will take place from 1:00-3:30pm ET, via Zoom, and is intended to provide information to animal drug manufacturers about new enhancements to the system.
In December 2021, the FDA announced an eSubmitter update intended to enable animal drug manufacturers to provide more complete facility information, particularly about the establishments that are actively used in their manufacturing processes, in order to provide supply chain data that strengthened the FDA’s ability to monitor the animal drug supply chain. This facility information is required to be submitted to the agency. This enhancement was part of the ADMS, a project funded by The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the COVID-19 public health emergency.
The ADMS webinar will explain the rationale for collection of supply chain information; include live demonstrations of users entering information into the various ADMS Books and eSubmitter templates, focused on the updated functionality; and will provide a live Q&A section where users can ask questions about the system and the new enhancement for sharing supply chain information.
The webinar is intended for:
- eSubmitter users for Drug Product and Drug Substance submissions;
- Drug Product and Drug Substance manufacturers, including Third Party/Contract manufacturers;
- US Agents and Consultants; and
- Government agencies involved in the pharmaceutical supply chain
To register for the webinar, please visit Webinar Registration - Zoom (zoomgov.com) and complete the required fields. If you would like to submit questions for the Q&A portion of the webinar in advance, please submit them to firstname.lastname@example.org with the subject line “Live ADMS Webinar” by Tuesday, June 17.
- Opening Remarks
- Introduction to ADMS
- Using ADMS Books
- Submission Templates
- Live Q&A
A recording of the webinar will be posted on this webpage and on the CVM eSubmitter Resource Center webpage when available.
- CVM eSubmitter Programs
- CVM eSubmitter Resource Center
- FDA Announces eSubmitter Update to Enhance Monitoring of Animal Drug Supply Chain