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20080208 Dia Edm Maximizing Metadata Oberhofer

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

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

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  • Intro – in regulatory business, not in IT We’ve seen two excellent presentations by Ed and Gabor on methods for the collection of robust metadata and how we’re positioning ourselves through products and standards to be able to leverage this “data about data”. The nice thing about the DIA conference is that we’re all coming here from widely varying companies running the gamut from small bio-sciences start-up to established global enterprises. 06/06/09 11:08 AM DjO Dia Presentation

20080208 Dia Edm Maximizing Metadata Oberhofer 20080208 Dia Edm Maximizing Metadata Oberhofer Presentation Transcript

  • Maximizing the Value of Metadata in Regulatory Submissions Repositories Dennis Oberhofer eRecords Center of Expertise Lead Information and Records Management
  •  
  •  
    • “ eArchive” = Repository or system
    • All data in charts/graphs/screenshots depict SAMPLE DATA . It’s not indicative of Pfizer’s actual performance or programs of work.
    • Technology Agnostic – Examples are not prescriptive nor endorsements of any technology or product.
    “ Ground Rules”
    • Collecting Robust Metadata
    Overview
    • Leveraging Quality Metadata
    • Measuring workload and regulatory milestone progress
    • Business process enablement: CMC Supplement subscription
    • Health Authority relationship metrics and process monitoring
    • The metadata collected must be of high quality to enable business intelligence applications and reliable process workflow.
  • “ Free Text” is the Enemy of Business Intelligence
  • Logging (the hard kind)
    • Can be electronic document management system (EDM) or records management system for hard-copy records
    • Robust enough to enable retrieval and business processes
      • Onerous process can reduce compliance
      • Excess logging wastes time and money if you never leverage the information
    • Captured at the submission and correspondence level, not the document level (e.g. FDA form level)
    Enabling Robust Metadata Collection
  • Introducing RADARS Winner 2007 PGRD Team Award
  • RADARS: Under the Hood
  • RADARS Metadata Collection
    • Metadata driven system; submissions and correspondence are auto-filed by what they are (not where they are)
    • Minimum metadata collected to facilitate retrieval and business process/intelligence
    • Guided Logging – Only displays attributes germane to type of submission being logged
    • Logging and uploading process takes approximately 5 minutes
    • New build-system coming on-line; logging information will almost entirely be collected as the submission is built
  • Logging Example - IND
    • Inter-document link support and full-lifecycle eCTD viewer allow submission to be viewed exactly as it was sent to the Health Authority
    Inter-document Link Support & eCTD Viewer
  • Feature Overview: Search and Retrieval
    • Complete chronology of application from pre-application throughout life of product
    Advanced Reporting
    • The timeline gives context to submissions and contact reports along the continuum.
    • Generates a complete chronology of all submissions and communications with Health Authorities instantly.
    Submission Continuum
    • Understanding the volume and nature of your submissions can help manage workload, trigger processes and measure progress toward regulatory goals.
  •  
  • Submission Volume Metrics Submission Date Submission Type Submission Media eCTD Gateway Site (Auto-Populated)
    • Business Objects (BO) universe created that reads Documentum’s Oracle tables in real-time
    • BO “does the math”, performing the counts and slicing & dicing
      • By Type
        • Major
        • Support
        • Pre-Marketing
        • Post-Marketing
        • “ Specialty” (DMF, Listings, Establishment)
      • By Site
      • By media (Electronic / Paper)
    Submission Metrics Reports
  • Metrics & Milestones SAMPLE DATA - NOT REPRESENTATIVE OF ACTUAL PERFORMANCE
  • Submissions by Type and Media SAMPLE DATA - NOT REPRESENTATIVE OF ACTUAL PERFORMANCE
  • Year-over-Year Performance SAMPLE DATA - NOT REPRESENTATIVE OF ACTUAL PERFORMANCE
    • Enables resource balancing & workload forecasting
    • By measuring volumes at sites, we can determine where excess capacity may lie
    • By comparing upcoming pipeline to past demands & performance, we can anticipate upcoming workload pressures
    Metrics Reporting Benefits
  •  
  • Process Flow Import / Export Compliance Rep Regulatory Submissions Group
  • Set Criteria & Save Search
  • Criteria Met = eMail Triggered
  • Content Instantly Available
  •  
    • PDUFA IV negotiations gave us clear, measurable goals for enhancing the process for:
      • Pre-market review
      • Transforming the post-market drug safety system
    • Opportunity to strengthen relationship with FDA and become more efficient and responsive
    • Helps answer questions for your company FDA is asking across the industry
    Example: PDUFA Metrics
    • Established PDUFA Tracking and Engagement Program (PTEP)
    • Approximately 44 goals in PDUFA IV; 19 pertain to regulatory review efficiency.
      • 15 carry from PDUFA III, only four are new
    PDUFA IV
    • We already measure our regulatory “customer service” performance – responsiveness to queries by health authorities
    • Extend capability to track PDUFA goals
    • Surfaced data for at least 5 of the metrics:
    • Meeting requests
    • Supplement/NDA first action timing
    • Advertisement review
    • More data points = more intelligence
    • Clinical hold response
    • Re-submission
    • 74 day letter logic
    • Compare performance to industry norms
    PDUFA Data Points
    • Extending Our Capabilities
    What’s Next?
    • Trending/mining regulatory issues
    • Performance tracking and planning regulatory agenda (anticipated filings)
    • Document production for litigation and inspection support (aided by full-text search)
  • 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
  • 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]