DIA Electronic Document Management 2011 Explores Global Standards Development and Implementation
EDM 2011 is the premier forum for discussing, refining, and advancing emerging standards and processes for the creation, submission, and retention of regulatory information.
Horsham, PA (Vocus/PRWEB) January 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 Reuse Paper 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.”
Register for Electronic Document Management 2011.
ABOUT DIA
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.
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