FLAGSHIP EVENT  

 

 

FUNDAMENTALS AND BEST PRACTICES OF DOCUMENT AND RECORDS MANAGEMENT

Register three get one FREE! 

 

In the past, DIA's EDM programs have focused on the life science industry's move toward electronic information exchange and the wave of standards and initiatives to support this transformation. This year's event will return to its grass roots to present a retrospective of the processes upstream and downstream of the regulatory submission process, content management from creation to archive, optimization, repurposing, and channeling information across the enterprise.    

Featured Topics

  • Electronic Health Records
  • Document/Records Management
  • Content Reuse Across the Common Technical Document
  • How Recent Developments in CTD Content and Structured Content Affect Medical Writers
  • Harmonization of Standards and Health Information Technology
  • Managing Submissions with Partners
  • Standards-based Approach to Identity Management and Digital Signatures for Interoperability Across the Pharmaceutical and Healthcare Sectors
  • Metadata: The Future of Electronic Document Management
  • Regulatory Compliance and Computerized Systems Validation
  • Process Integration Through EDMS Solutions
  • eCTD Planning/Workflow
  • Regulatory Updates

Keynote Speakers

Janet Marchibroda, CEO, eHealth Initiative
Charles Jaffe, MD, PhD, Former CEO, HL7

Reception

Wine Tasting for Dummies 
Thursday, February 7
6:30 - 8:30 pm


Pre-conference Tutorials

  • eIND
  • Practical Management of eCTD Lifecycle
  • Compliance: Avoiding Costly Submission Errors
  • Guidance-compliant eCTDs
  • Authoring Medical Templates 
  • Validation of Computerized Systems for Regulated Electronic Records, Documents, and Submissions

Special Training Course
Development of a Clinical Study Report

Contact Information
Conference
Joanne.Wallace@diahome.org
Exhibits
Erin.Gilliland@diahome.org