Reference Models and the Framework for the Destruction of Paper: How They Are Changing Our Industry
Track
:
Track 19: SIAC Showcase
Program Code:
273
Date:
Tuesday, June 26, 2012
Time:
3:30 PM to 4:30 PM
EST
CHAIR
:
Lisa Mulcahy, Mulcahy Consulting, LLC, United States
Lisa has extensive experience having worked as a Study Coordinator, at a CRO, and a biotech co. and in large pharma in both Trial Mgmt and Quality & Compliance. She is now a content management consultant, working solely on TMF projects. She is DRM SIAC Chair & co-Leader of the DIA TMF Ref. Model.
Global Business Development Director at Phlexglobal, leading the eTMF initiative. Co-chair of the DIA TMF Reference Model. Experienced in Clinical Project Management and Trial Master Files.
Antoinette Azevedo founded e-SubmissionsSolutions.com (a California corporation) to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions.
Description
The recent release of the Framework for the Destruction of Paper adds to the already widely used reference models that have been developed by the very active members of the Document and Records Management (DRM) SIAC. Join this session to review the DRM SIAC's mission and ongoing activities already underway including the released version 2.0 expansions of the Trial Master File Reference Model, the recent updates to the EDM-Submission Reference Model and introduce the very newly finalized Framework for the Destruction of Paper. Developed by the Document and Records Management (DRM) SIAC.
Learning Objectives: Describe how the EDM-Submission and TMF Reference Models are being utilized by large and small companies Describe recent updates to the reference models Identify the Framework for the Destruction of Paper that has been digitalized Recognize how the DRM SIAC work groups organize and network for the purpose of solving industry challenges.