Meeting+Minutes+Aug-27-08+DL&ER+Workgroup

Aug 27 2008, 11 am EDST**   **1. Training Opportunities: ** //Upcoming DIA Meetings: // Structured Product Labeling (SPL): Preparing for FDA Electronic Drug Registration and Drug Listing October 29 - 30 | Philadelphia, PA
 * SPL Process Team - DL&ER Workgroup
 * Meeting Minutes **

**2. WIKI website:** A group of people from the SPL Process team have been updating a website as a reference point for all of the SPL changes. There are Q&As for different topics. Please visit the site and provide feedback.  Several topics were discussed regarding the guidance document. Comments were fed into PhARMA to be submitted to Agency. Individuals also submitted on their own.
 * 3. Responses to Guidance document, due to FDA on Sept. 9th**

A member of the team had a discussion with the President of Global submit and leanred that the XForms interface was only to be used for testing purposes and will not be supported in the future. Sponsors will have to rely on other software for SPL creation.
 * 4.** **XForms interface:**

A training session with FDA is open for those who would like to participate. A webinar will be set up between organizations and FDA and will walk through their actual process to find any kinks along the way. Case Studies will be created based on these sessions (sponsors can change the information to keep it confidential) and these will be posted on the WIKI for informational purposes. This will be a valuable tool for all to use in the future. Any volunteers can contact either me or spl@fda.hhs.gov.
 * 5. Training session with FDA**


 * 6. Next meeting will be on Sept. 10, 2008 at 10 am EDST.**