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Integrating Pharmacovigilance Into Quality Management System First Annual CAPA Congress Boris Videlov
Disclosure <ul><li>This presentation is intended to be used for informational purposes only </li></ul><ul><li>The views ex...
Why have a Pharmacovigilance QMS? <ul><li>Regulations </li></ul><ul><ul><li>Governmental: US CFR, EU (EMEA, MHRA, etc) </l...
Pharmacovigilance Process
Monitoring Metrics Reports <ul><li>Focused, Intelligent, Simple </li></ul><ul><li>Ensure system upgrades do not affect the...
Metrics Examples
Considerations for QMS <ul><li>Paper vs. Electronic vs. Hybrid </li></ul><ul><ul><li>If Electronic </li></ul></ul><ul><ul>...
Electronic System(s) Selection <ul><li>Single system versus multiple systems </li></ul><ul><li>Available Systems </li></ul...
Potential Challenges <ul><li>Unnecessary standard fields </li></ul><ul><li>Integration with other systems </li></ul><ul><u...
Likely Customization and Enhancements <ul><li>Custom Fields </li></ul><ul><li>Custom Tables/Grids </li></ul><ul><li>Custom...
Identification of Quality & Compliance Issues <ul><li>Data coming from different sources and systems </li></ul><ul><li>Use...
Quality Management of Document Review <ul><li>Shared company/departmental responsibility </li></ul><ul><li>Routine and Ad-...
Quality Management of Contracting <ul><li>Company-wide process </li></ul><ul><li>Contractors – viewed by the authorities a...
Quality Management of In- and Out-licensing <ul><li>First step - Due Diligence </li></ul><ul><li>Licensing Agreements/Deve...
Quality and Compliance of CT Data (slide 1 of 2) <ul><li>Paper SAE Form vs. EDC  </li></ul><ul><li>Before the trial begins...
Quality and Compliance of CT Data (slide 2 of 2) <ul><li>After the trial begins </li></ul><ul><ul><li>Compliance Monitorin...
Compliance and Quality Monitoring of Business Partners <ul><li>Compliance Monitoring </li></ul><ul><ul><li>Exchange Metric...
Compliance with Company AE Reporting Policy <ul><li>Governance </li></ul><ul><ul><li>Corporate Standard for AE Reporting b...
Compliance Management of Expedited ICSRs <ul><li>Useful QMS fields </li></ul><ul><ul><li>( 1 ) The data is usually availab...
Compliance and Quality Management of Aggregate Reports <ul><li>Interdepartmental Process </li></ul><ul><li>Use of Document...
Quality Management of ICSRs <ul><li>Prospective Quality Checks </li></ul><ul><ul><li>Performed in Drug Safety Database, so...
Retrospective Quality Review <ul><li>A defect will never occur until the unit has passed final inspection! Murphy’s Law </...
Quality Management of the Signaling Process <ul><li>RCA: </li></ul><ul><ul><li>Potential Safety Signal Identification </li...
Quality Management of Inspections/Audits Records <ul><li>Classify Inspections/Audits </li></ul><ul><ul><li>External </li><...
Quality Management of Data Verification <ul><li>Ensures the integrity and quality of the entire database or data subset </...
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Pharmacovigilance Quality Management System

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FDA News Presentation

  1. 1. Integrating Pharmacovigilance Into Quality Management System First Annual CAPA Congress Boris Videlov
  2. 2. Disclosure <ul><li>This presentation is intended to be used for informational purposes only </li></ul><ul><li>The views expressed herein are those of the author and do not necessarily represent the views of Forest Research Institute or any of its staff </li></ul>
  3. 3. Why have a Pharmacovigilance QMS? <ul><li>Regulations </li></ul><ul><ul><li>Governmental: US CFR, EU (EMEA, MHRA, etc) </li></ul></ul><ul><ul><li>International: ICH (Q 9 &10), CIOMS, ISO </li></ul></ul><ul><ul><li>Professional/Certification: BARQA, TQM, 6 σ , ASQ, Lean </li></ul></ul><ul><li>Industry Standards </li></ul><ul><ul><li>Good Pharmacovigilance Practice (GPvP) http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/index.htm </li></ul></ul><ul><ul><li>GCP and Good Documentation Practices </li></ul></ul><ul><li>Company Procedures </li></ul><ul><ul><li>Corporate Requirements </li></ul></ul><ul><ul><li>Process requirement from Corporate Quality </li></ul></ul><ul><ul><li>Pharmacovigilance Departmental requirement </li></ul></ul><ul><li>Contractual Agreements </li></ul><ul><li>Regulatory Inspections </li></ul>
  4. 4. Pharmacovigilance Process
  5. 5. Monitoring Metrics Reports <ul><li>Focused, Intelligent, Simple </li></ul><ul><li>Ensure system upgrades do not affect the reports </li></ul><ul><li>Use of various Report Systems: SDB, BO, QMS </li></ul><ul><li>Establish Reports Tracking, Periodicity, Targets, and Ranges </li></ul><ul><li>Define Trend </li></ul><ul><li>Discuss with the appropriate audience and close the loop </li></ul>
  6. 6. Metrics Examples
  7. 7. Considerations for QMS <ul><li>Paper vs. Electronic vs. Hybrid </li></ul><ul><ul><li>If Electronic </li></ul></ul><ul><ul><ul><li>Validated (DB) vs. not-validated (xls) </li></ul></ul></ul><ul><ul><ul><li>Commercial system vs. in-house developed system </li></ul></ul></ul><ul><li>Internal Knowledge vs. External Consulting </li></ul><ul><li>Inspection commitment vs. company initiative </li></ul><ul><li>Availability of financial resources and people </li></ul><ul><li>Regulatory Risk Assessment </li></ul><ul><li>Benefits vs. Cost Analysis </li></ul>
  8. 8. Electronic System(s) Selection <ul><li>Single system versus multiple systems </li></ul><ul><li>Available Systems </li></ul><ul><ul><li>Off-the-shelf system use </li></ul></ul><ul><ul><li>Re-configuration: effort and cost </li></ul></ul><ul><li>New System Selection </li></ul><ul><ul><li>System/Vendor selection </li></ul></ul><ul><ul><li>New System Implementation/validation: effort and cost </li></ul></ul>
  9. 9. Potential Challenges <ul><li>Unnecessary standard fields </li></ul><ul><li>Integration with other systems </li></ul><ul><ul><li>Drug Safety Database </li></ul></ul><ul><ul><li>Reporting Tools </li></ul></ul><ul><ul><li>Learning (Knowledge) Management System </li></ul></ul><ul><ul><li>SOP/Document Management </li></ul></ul><ul><li>Record structure </li></ul><ul><ul><li>Sub-records (hierarchy) </li></ul></ul><ul><ul><li>Linking related records </li></ul></ul><ul><ul><li>Support for table format data </li></ul></ul><ul><li>Develop customized intelligent reports </li></ul><ul><li>Support Continuous Improvement </li></ul>
  10. 10. Likely Customization and Enhancements <ul><li>Custom Fields </li></ul><ul><li>Custom Tables/Grids </li></ul><ul><li>Custom Reports and integration with third-party Report Builders </li></ul><ul><li>Data Export in desired format </li></ul><ul><li>Links to other databases </li></ul><ul><li>Activities completion timeframe flexibility </li></ul><ul><li>On-screen Help Tips and other Links to Procedures or User Guides </li></ul>
  11. 11. Identification of Quality & Compliance Issues <ul><li>Data coming from different sources and systems </li></ul><ul><li>Use of dashboards to monitor data simultaneously </li></ul>
  12. 12. Quality Management of Document Review <ul><li>Shared company/departmental responsibility </li></ul><ul><li>Routine and Ad-hoc </li></ul><ul><li>Document Types: </li></ul><ul><ul><li>Internal Procedural Documents </li></ul></ul><ul><ul><li>External Procedural Documents </li></ul></ul><ul><ul><li>Clinical Trial Protocols/Amendments </li></ul></ul><ul><ul><li>CRO documents </li></ul></ul><ul><ul><li>Safety Data Exchange Agreements </li></ul></ul><ul><ul><li>Marketing Materials </li></ul></ul><ul><li>System Integration with Document Management System </li></ul>
  13. 13. Quality Management of Contracting <ul><li>Company-wide process </li></ul><ul><li>Contractors – viewed by the authorities as extensions of the company </li></ul><ul><li>Difficult to control affiliates’ contractual activities </li></ul><ul><li>Joint effort between Drug Safety, Product Development, Procurement, Clinical Development, Corporate Quality, Marketing, Legal, and other departments </li></ul><ul><ul><li>Negotiate inter-departmental process </li></ul></ul><ul><ul><li>Use of Contract Management System </li></ul></ul><ul><li>Requires subsequent Training and Monitoring </li></ul>
  14. 14. Quality Management of In- and Out-licensing <ul><li>First step - Due Diligence </li></ul><ul><li>Licensing Agreements/Development Agreements/Quality Agreements </li></ul><ul><li>Safety Data (PhV) Exchange Agreements </li></ul><ul><ul><li>Process for development and maintenance </li></ul></ul><ul><ul><li>Consider using a database (eg, Contract Management System) </li></ul></ul><ul><ul><li>Maintain key timeframes reference document/report </li></ul></ul><ul><ul><li>Include compliance clauses: </li></ul></ul><ul><ul><ul><li>Compliance with applicable regulations and agreements </li></ul></ul></ul><ul><ul><ul><li>Response timeframes for compliance issues </li></ul></ul></ul><ul><ul><ul><li>PhV Audits </li></ul></ul></ul><ul><ul><ul><li>Escalation of issues </li></ul></ul></ul><ul><ul><ul><li>Penalties </li></ul></ul></ul>
  15. 15. Quality and Compliance of CT Data (slide 1 of 2) <ul><li>Paper SAE Form vs. EDC </li></ul><ul><li>Before the trial begins </li></ul><ul><ul><li>CT Protocol review </li></ul></ul><ul><ul><ul><li>SAE and unblinding sections </li></ul></ul></ul><ul><ul><ul><li>Forms customization </li></ul></ul></ul><ul><ul><li>Site/Principal Investigator Selection </li></ul></ul><ul><ul><li>Coordinator and Investigator Meetings </li></ul></ul><ul><ul><ul><li>Investigator Binder/CD preparation </li></ul></ul></ul><ul><ul><ul><li>Training materials </li></ul></ul></ul>
  16. 16. Quality and Compliance of CT Data (slide 2 of 2) <ul><li>After the trial begins </li></ul><ul><ul><li>Compliance Monitoring </li></ul></ul><ul><ul><ul><li>Timeframes for SAE Form submission to Sponsor (incoming) </li></ul></ul></ul><ul><ul><ul><li>Query response timeframes (incoming) </li></ul></ul></ul><ul><ul><ul><li>Investigator notifications (outgoing) </li></ul></ul></ul><ul><ul><li>Quality </li></ul></ul><ul><ul><ul><li>SAE Form completeness and accuracy </li></ul></ul></ul><ul><ul><ul><li>Query volume to sites and trends </li></ul></ul></ul><ul><ul><ul><li>Discrepancies between Clinical Database and Drug Safety Database during reconciliation </li></ul></ul></ul><ul><ul><li>CRO Audits </li></ul></ul><ul><ul><li>CAPA – collaboration with Corporate Quality & Clinical Development/Operations </li></ul></ul>
  17. 17. Compliance and Quality Monitoring of Business Partners <ul><li>Compliance Monitoring </li></ul><ul><ul><li>Exchange Metrics Reports for compliance with timelines </li></ul></ul><ul><ul><li>Identify non-conformances </li></ul></ul><ul><ul><ul><li>Request Reason for Delay and CAPA </li></ul></ul></ul><ul><ul><ul><li>Trend and perform Effectiveness Checks </li></ul></ul></ul><ul><li>Quality Monitoring and feedback from Drug Safety Operations </li></ul><ul><li>Actions </li></ul><ul><ul><li>Official Notification/Memorandum </li></ul></ul><ul><ul><li>Minuted teleconference to discuss CAPA </li></ul></ul><ul><ul><li>F2F meeting </li></ul></ul><ul><ul><li>PhV Audit </li></ul></ul><ul><ul><li>Escalation to Corporate/Legal </li></ul></ul>
  18. 18. Compliance with Company AE Reporting Policy <ul><li>Governance </li></ul><ul><ul><li>Corporate Standard for AE Reporting by company employees </li></ul></ul><ul><ul><ul><li>Documented Training </li></ul></ul></ul><ul><li>Data from multiple databases: </li></ul><ul><ul><li>HR System or Training Management System to monitor overall training and retraining compliance </li></ul></ul><ul><ul><li>Drug Safety Database for monitoring compliance with the policy </li></ul></ul><ul><ul><li>QMS for tracking of compliance, trends, RCA, and CAPA </li></ul></ul><ul><li>Enforcement is a joint effort </li></ul>
  19. 19. Compliance Management of Expedited ICSRs <ul><li>Useful QMS fields </li></ul><ul><ul><li>( 1 ) The data is usually available in SDB </li></ul></ul><ul><ul><li>( 2 ) Additional compliance data is required </li></ul></ul><ul><ul><li>Clock Start Date 1 /Due Date 1 /Actual Submission Date 1 /Delay in Days 2 </li></ul></ul><ul><ul><li>Additional information 2 </li></ul></ul><ul><li>Group Responsible </li></ul><ul><ul><li>Company Name 1, 2 </li></ul></ul><ul><ul><li>External vs. Internal group 2 </li></ul></ul><ul><ul><li>Department/Functional Group 1, 2 </li></ul></ul><ul><ul><li>Reason for Delay 2 </li></ul></ul><ul><ul><li>Delay in Days 2 </li></ul></ul><ul><li>Workflow Step where the delay occurred 1, 2 </li></ul><ul><li>ID fields </li></ul><ul><ul><li>ICSR ID 1 </li></ul></ul><ul><ul><li>Reporter (Business Partner) ID 1 </li></ul></ul><ul><ul><li>Version # 1 </li></ul></ul><ul><ul><li>Approval # 1 </li></ul></ul><ul><li>Product Name(s) 1 </li></ul><ul><li>Authority fields </li></ul><ul><ul><li>Health Authority 1 </li></ul></ul><ul><ul><li>Report Type 1 </li></ul></ul>
  20. 20. Compliance and Quality Management of Aggregate Reports <ul><li>Interdepartmental Process </li></ul><ul><li>Use of Document Management System </li></ul><ul><li>Report Schedule Tracking </li></ul><ul><li>In-Process Quality Checks and Sign-offs </li></ul><ul><li>Submission Tracking and Monitoring </li></ul><ul><li>Subject to Retrospective Quality Review </li></ul>
  21. 21. Quality Management of ICSRs <ul><li>Prospective Quality Checks </li></ul><ul><ul><li>Performed in Drug Safety Database, some may be documented in QMS </li></ul></ul><ul><ul><li>Electronic (system) </li></ul></ul><ul><ul><li>Peer/Supervisor/Medical Review </li></ul></ul><ul><li>Retrospective Quality Review </li></ul><ul><ul><li>Performed in DSB, documented in QMS </li></ul></ul><ul><ul><li>All vs. Targeted data fields </li></ul></ul><ul><ul><li>Prioritization of ICSRs to be reviewed </li></ul></ul><ul><ul><ul><li>By expeditedness </li></ul></ul></ul><ul><ul><ul><li>By case type </li></ul></ul></ul><ul><ul><ul><li>By case volume </li></ul></ul></ul><ul><ul><ul><li>By known issues </li></ul></ul></ul><ul><ul><ul><li>By available resources </li></ul></ul></ul>
  22. 22. Retrospective Quality Review <ul><li>A defect will never occur until the unit has passed final inspection! Murphy’s Law </li></ul><ul><li>Periodic retrospective quality review on a sample of items (ICSRs, aggregate reports) </li></ul><ul><li>Use standard statistical formula/calculations [example] SS = Z 2 * (p) * (1-p) / c 2 </li></ul><ul><li>Determine appropriate Sample Size, based on statistical parameters: </li></ul><ul><ul><ul><li>Confidence Interval </li></ul></ul></ul><ul><ul><ul><li>Confidence level </li></ul></ul></ul><ul><ul><ul><li>Percentage picking a choice </li></ul></ul></ul><ul><li>Additional criteria to select priority items (eg, expedited reports) </li></ul><ul><li>Trending, RCA, CAPA, and Effectiveness Check </li></ul>
  23. 23. Quality Management of the Signaling Process <ul><li>RCA: </li></ul><ul><ul><li>Potential Safety Signal Identification </li></ul></ul><ul><ul><li>Safety Signal Investigation </li></ul></ul><ul><ul><li>Safety Signal Evaluation </li></ul></ul><ul><ul><li>Impact Analysis </li></ul></ul><ul><li>CAPA: </li></ul><ul><ul><li>Changes to Reference Safety Information </li></ul></ul><ul><ul><li>Aggregate Reports </li></ul></ul><ul><ul><li>Pre-planned Actions in REMS/RMP/Risk Maps </li></ul></ul><ul><ul><li>Other Actions </li></ul></ul>
  24. 24. Quality Management of Inspections/Audits Records <ul><li>Classify Inspections/Audits </li></ul><ul><ul><li>External </li></ul></ul><ul><ul><ul><li>Regulatory Inspections </li></ul></ul></ul><ul><ul><ul><li>Business Partner Audits </li></ul></ul></ul><ul><ul><li>Internal </li></ul></ul><ul><ul><ul><li>Internal Audits </li></ul></ul></ul><ul><ul><ul><li>Business Partner/CRO Audits </li></ul></ul></ul><ul><li>Tracking of specific data </li></ul><ul><ul><li>Request Type/Details </li></ul></ul><ul><ul><li>Data Date Range </li></ul></ul><ul><ul><li>Date Requested/Date Provided/Taken off-site </li></ul></ul><ul><li>Findings/Observations </li></ul><ul><li>Root Cause Analysis and Company Commitments (CAPA) </li></ul>
  25. 25. Quality Management of Data Verification <ul><li>Ensures the integrity and quality of the entire database or data subset </li></ul><ul><li>Full data verification vs. sample </li></ul><ul><li>Routine </li></ul><ul><ul><li>Clinical Database </li></ul></ul><ul><ul><li>Product Quality Complaints Database </li></ul></ul><ul><ul><li>Medical Communications Database </li></ul></ul><ul><li>Ad hoc </li></ul><ul><ul><li>Database Upgrade/Migration </li></ul></ul><ul><ul><li>Data(base) Transfer </li></ul></ul><ul><ul><li>Data Cleansing </li></ul></ul>
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