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Electronic Document Management 2011 Explores Global Standards Development and Implementation

Horsham, PA, USA — Jan 11, 2011

DIA will host Electronic Document Management 2011: The Intersection of Data, Documents, and Submissions from February 14-16 in National Harbor, MD.

EDM 2011 is the premier forum for discussing, refining, and advancing emerging standards and processes for the creation, submission, and retention of regulatory information. Additionally, the design and development of business processes to facilitate the conversion of data into document components resulting in high quality regulatory submissions will be examined. Managing information in a completely electronic environment and enabling the current and future electronic submission standards landscape are key focuses. Topics include:

  • Structured Authoring
  • DDMAC – Processes and Submissions
  • Sharepoint
  • Leveraging Standards and Technology to Streamline Content
  • Authoring and Reuse
  • A Construct for Successfully Managing Transformational Change of Regulatory Submission Processes and Technical Solutions
  • Migration of Regulated Data and Records
  • Regulatory Information Management
  • Evolving Trends
  • Records and eArchive
  • Getting the Most from Your Document Management System
  • Submissions and Business Technology: A Case Study on Achieving Submission Readiness Through Innovative Technology and Standards
  • Regulatory Submission Strategy for Global Regulated Products - Business Intelligence, Regulatory Information Management and Content ReusePaper to Electronic
  • Leveraging Standards and Technology to Improve Business Process Definition and Execution
  • Compliance and Information Management
  • Regulatory Updates
  • FDA Town Hall
  • Document Granularity
  • eTMF The Trial Master File Reference Model and Industry Interpretations
  • IRISS Forum and eCTD Interoperability

David Miller, Chief Security Officer at Covisint will deliver the keynote address on “Document Access Management in a New Century: What the Pharmaceutical Industry Must Do to Avert Its Own WikiLeak Disaster Specific points of discussion include:

  • Access privileges for various types of users
  • Usage and identifying individuals that are “abusing” privileges
  • Techniques such as “white lists” and “black lists” in conjunction with traditional access control models
  • Access granting decisions across extended organizations
  • Real-world access control scenarios in Pharma, HealthCare and Manufacturing

“Over the past 23 years, the DIA EDM Conference has served as a forum for the discussion of emerging standards and the processes for the creation, submission and retention of regulatory information,” says Program Co-chair Joseph A. Cipollina, Senior Director, Operational Excellence and Business Improvement, Worldwide Safety and Regulatory Operations, Pfizer Inc. “This year’s program has been enhanced to provide a more comprehensive and interactive experience. The renewed approach affords opportunities to learn about and discuss the benefits and challenges of global standards development and implementation.”





ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.