 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Two training sessions are being offered to individuals responsible for the preparation and submission of drug registration and listing information to the FDA.
Background: The FDA Amendments Act placed into law the requirement for electronic establishment registration and drug listing. Release 4 of Structured Product Labeling (SPL) contains data elements that could enable this process. A face-to-face meeting will provide training on SPL release 4 and its potential for meeting the recent changes to the establishment registration and drug listing requirements. A preparatory webinar is also being offered to those planning on attending the face-to-face meeting. The webinar will provide an overview of basics of SPL and an introduction to registration and listing changes. The face-to-face discussion will provide a more in-depth review of specific proposed changes to SPL including new terminologies.
Targeted audience: Individuals responsible for establishment registration and drug listing for pharmaceutical, biologic, OTC and animal products are strongly encouraged to attend.
1. SPL Release Four Evaluation Material for Registration and Listing Version 0.2
2. FDA Amendment Act of 2007 - Section 224 - Electronic Registration and Listing
Date: Wednesday, February 20, 2008
Time: 1:00 p.m. – 2:30 p.m. EST
Date: Wednesday, February 27, 2008
Time: 12:00 p.m. – 5:00 p.m.
Location: Food and Drug Administration, 5630 Fishers Lane, Conference Room 1066, Rockville, MD 20857
There is no registration fee for either training session, but pre-registration is required because of limited connections for the webinar, and limited seating for face-to-face meeting.
Due to space limitations, only two individuals per organization will be permitted to attend the face-to-face meeting. To register, please submit your first and last name and the name of your organization to spl@fda.hhs.gov.
For further information, contact: spl@fda.hhs.gov.