NLM Hosts an Open Meeting of the Structured Product Labeling (SPL) Working Group Leadership Team
The NLM will host the SPL Working Group's SPLIMAGE Workshop, to be held at the NLM Boardroom in Bethesda, MD on July 26, 2012, 10 AM to 4 PM.
In recent years, NLM has been working toward developing the methods and infrastructure for digital photographs of prescription oral solid dose medications (prescription pills, tablets, and capsules). A complete, comprehensive portfolio of the nation's prescription formulary would have a profound impact on consumer safety.
On May 23, 2011, NLM posted a Federal Register Notice (Vol. 76, No. 99, FR Doc. 2011-12629, //www.gpo.gov/fdsys/pkg/FR-2011-05-23/html/2011-12629.htm), seeking sources of medications to develop the photographic techniques to capture this information. In June 2012, the first results of an ongoing study of digital photographs of voluntarily submitted medications by pharmaceutical manufacturers were released.
In response, the Structured Product Labeling (SPL) Working Group Leadership Team is convening a meeting to gather information about the process and techniques on digital photography and data acquisition. Topics to be discussed include:
Digital Photography of SPLIMAGE
Early Experience with the SPLIMAGE data - Respondents to the NLM FR Notice
- Sponsors perspective(s)
DailyMed & possible downstream uses
- Use of the SPLIMAGE specification outside of NLM photography
- Updated sample provision process?
- Possible issues and concerns
While the meeting is an open forum of the SPL Working Group, space in the room is limited. Specific invitations have been made to a number of sponsors (including all those who provided samples in response to the May 2011 Federal Register notice), FDA representatives involved with SPL and the SPLIMAGE discussions, NLM representatives involved with the SPLIMAGE image production and dissemination, and potential downstream users of the SPLIMAGEs as they become available.
Outcomes from the discussions will be disseminated via the usual SPL Working group communication channels (SPL Working Group WIKI, cascades through e-mail, LinkedIn, presentations at SPL WG subteam meetings, and potentially others).
Please note that the content of the meeting is the subject of the organizers and is not representative of NLM.
If you have any questions about the meeting or if you would like to attend, contact the SPL Working Group Leadership Team through Terry Brunone (Theresa.M.Brunone@gsk.com).