Public Workshop
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HL7 SPL Working Group Electronic Drug Registration and Listing Meeting Thursday, May 15, 2008 (Webinar)
A training session is being offered to individuals responsible for the preparation and submission of drug registration and listing information to the FDA. This webinar will include real-world biologics examples of Establishment Registration and Drug Listings.
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. This preparatory webinar is being offered to provide an overview of basics of SPL and an introduction to registration and listing changes.
Targeted audience: Individuals responsible for establishment registration and drug listing for biologic products are strongly encouraged to attend.
Background information:
1. Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Content of Labeling.
2. SPL Release 4 Evaluation Material for Registration and Listing Version 0.3 (ZIP - 399 KB)
(If you have problems or questions about this ZIP file, please contact Melanie Whelan at
301-827-2000 or CBERTraining@fda.hhs.gov)
3. FDA Amendment Act of 2007 - Section 224 - Electronic Registration and Listing (PDF - 383 KB)
Webinar Information:
Date: Thursday, May 15, 2008
Time: 11:00 a.m. – 12:30 p.m. EDT
Registration Information:
There is no registration fee for this training session, but pre-registration is required because of limited connections for the webinar.
To register, please email CBERTraining@fda.hhs.gov.
Subject line: HL7 SPL Working Group Electronic Drug Registration and Listing
Include your name, title, firm name, address, telephone number and fax number.
For further information contact Melanie Whelan at 301-827-2000.