1. www.diahome.org DIA DRM SIAC Content Re-Use Working Group March 22, 2012 Presenter:Sheila Jewels Strategy Consultant Virtify, Inc. sjewels@virtify.com

2. www.diahome.org DIA DRM SIAC Content Re-Use Working Group Mute please, no hold music! DIA neutral space Content on DIA Connex Must be a current DIA Member to participate Must join the DIA DRM SIAC to get the broadcasts and access to content

3. www.diahome.org Goals –Project charter Objectives- map, pilot –Discussion Teams –“Deliverables” Mapping Pilot –Theory 1.Clinical Protocol 2.CMC 3.Clinical Trial Disclosure 4.Labeling 5.Broader implications

4. www.diahome.org Schedule Alternate months –March- Group Meeting –April- Team Meeting –Etc. Team Meeting Agenda: –Deliverables teams will work on mapping, pilot definition –Theory team will discuss broader, long term implications of CRU Group Meeting Agenda: –Team Reports –Case Study DIA Annual Roundtables/meetings, EDM-eCTD, etc.

5. www.diahome.org Next Steps Please sign up for a team!! Email sjewels@virtify.com sjewels@virtify.com Parking lot discussions Volunteer to do a case study

6. www.diahome.org Thank you sjewels@virtify.com