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.

ShareThis Email PDF Print

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.

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.”

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.

###