Presented to Drug Information Association Document Management Conference, February 8, 2008

1. Maximizing the Value of Metadata in Regulatory Submissions Repositories Dennis Oberhofer eRecords Center of Expertise Lead Information and Records Management

7. “ Free Text” is the Enemy of Business Intelligence

8. Logging (the hard kind)

10. Introducing RADARS Winner 2007 PGRD Team Award

11. RADARS: Under the Hood

13. Logging Example - IND

15. Feature Overview: Search and Retrieval

20. Submission Volume Metrics Submission Date Submission Type Submission Media eCTD Gateway Site (Auto-Populated)

22. Metrics & Milestones SAMPLE DATA - NOT REPRESENTATIVE OF ACTUAL PERFORMANCE

23. Submissions by Type and Media SAMPLE DATA - NOT REPRESENTATIVE OF ACTUAL PERFORMANCE

24. Year-over-Year Performance SAMPLE DATA - NOT REPRESENTATIVE OF ACTUAL PERFORMANCE

27. Process Flow Import / Export Compliance Rep Regulatory Submissions Group

28. Set Criteria & Save Search

29. Criteria Met = eMail Triggered

30. Content Instantly Available

36. Cornerstone of good records keeping practices + enables business intelligence Buy in from stakeholders, understanding from users Maximize the value of what you’ve already invested in Collect enough, but only what you need to

37. Maximizing the Value of Metadata in Regulatory Submissions Repositories Dennis Oberhofer eRecords Center of Expertise Lead Information and Records Management PHONE: 212-733-8472 eMail: [email_address]