Reshaping Global ICSR Reporting to Deliver Real-time Visibility and Oversight
Download as PPTX, PDF1 like840 views
The document discusses the evolving landscape of Individual Case Safety Reporting (ICSR) and pharmacovigilance, highlighting the challenges and opportunities presented by technology, data standardization, and regulatory changes. It emphasizes the need for a unified and connected pharmacovigilance solution to manage data and content effectively, streamline processes, and enhance collaboration. The document outlines the benefits of modernizing ICSR reporting, including improved efficiency, compliance with regulations, and better management of adverse drug reaction data.
Reshaping Global ICSR Reporting to Deliver Real-time Visibility and Oversight
- 1. 1 Copyright © Veeva Systems 2021 Reshaping Global ICSR Reporting to Deliver Real-time Visibility and Oversight Saba Darvesh, Sr. Director Vault Safety Strategy Mike Kruczek, Director Vault Safety Strategy
- 2. Saba Darvesh Sr. Director, Vault Safety Strategy Mike Kruczek Director, Vault Safety Strategy
- 3. Global ADR Data and Trends
- 4. 4 Copyright © Veeva Systems 2021 ICSR Volume Data FDA FAERS Public Dashboard (Mar 2021)
- 5. 5 Copyright © Veeva Systems 2021 ICSR Volume Data EMA PV Annual Report (2020) Figure 2 – Trend of ADR reports from patients and consumers received in the EEA by NCAs and MAHs and reported to EudraVigilance EudraVigilance continues to support the reporting of suspected unexpected serious adverse reactions (SUSARs) in accordance with EU clinical trial legislation14 (see Annex II)
- 6. 6 Copyright © Veeva Systems 2021 ICSR Volume Data NMPA PV Annual Report (2020) 1800000 1600000 1400000 1200000 1000000 800000 600000 400000 200000 0 Figure 1 - Trend in the number of reported adverse drug reactions / events nationwide from 1999 to 2020 Figure 3 - Source of adverse drug event reports for 2020
- 7. 7 Copyright © Veeva Systems 2021 Uppsala Monitoring Centre Annual Report Jul 2019 – Jun 2020 Additional Statistics from VigiBase Country distribution for ICSRs received over the year Country distribution in VigiBase for ICSRs received during the past 12 months, as of 30 June 2020 ICSRs per Million Inhabitants ICSRs received in VigiBase 2015 – 2020 (average to compensate for year-to-year fluctuations)
- 8. A Rapidly Evolving Global Reporting Landscape
- 9. 9 Copyright © Veeva Systems 2021 Evolving Global Reporting Landscape Evolving Regulatory Guidelines File Formats Data Integrity and Timeliness Solicited Monitoring Unsolicited Monitoring (PSP’s, SM, MLM) Data Quality Enhanced Oversight and Management
- 10. 10 Copyright © Veeva Systems 2021 Evolving Global Regulatory Landscape 2001 EudraVigilance Created 2012 2017 2018 2019 2020 2021 New EU GPV Guidelines Adopted New EudraVigilance Format China ICH Guideline Adopted 2016 ANVISA (Brazil) ICH Guideline Adopted FDA IND Cross Reporting China GVP Brazil VigiFlow Rollout FDA PBRER Adopted Mexico R3 (Cofepris) PMDA R3 Korea MFDS R3 EMA R3 Brexit – MHRA Russia, TGA, SAHPRA Updates FDA Combo Products FDA E2B R3, eVAERS, eMDR Health Canada R3
- 11. Looking to the Future Simplifying Global Reporting
- 12. 12 Copyright © Veeva Systems 2021 Analysis Reporting & Metrics Processing Intake Oversight & Management Submissions Gateway Current PV System Landscape Signal Tracking Local Reporting Business Objects – Case Management Cognos, Qlik – Metrics & user reporting Signal Detection Case Analysis Signal Management – Real Time Analysis of Clinical Cases Compliance Tracking & Remediation PV Agreements Tracking Receipt & Triage Reconciliation Log & Track Safety Support Issues Japanese Safety Database Safety Database Dictionary & Coding Mgt Safety Database Copy Data Mart PSMF, Local Trackers, Safety Letters, Investigator Communications Document Management ROW Document Management EU Literature Assessment Follow-up Letters, Clinical Queries & Tracking Aggregate Reporting
- 13. 13 Copyright © Veeva Systems 2021 Challenges Current PV System Landscape Opportunities • Technology Secure and manage data easily Maintaining data privacy Translation engines Analytics and Visualization of multi- dimensional data • Standardization Data format - E2B R2/R3 Coding of medical products and events - MedDRA (EMA, FDA), WHO DRUG, ATC • Multiple data sources • HQ & Affiliate model – siloed data sources • Unstructured data • Inconsistent coding • Different languages • Separate data and content systems • Data Governance & Management
- 14. 14 Copyright © Veeva Systems 2021 Unified and Connected Pharmacovigilance Solution Aggregate or Periodic Reporting Case Intake Partner Management Content Management Case Processing and Management Submissions and Distribution Signal & Risk Management Artificial Intelligence, Reporting, Analytics, Dashboards Other Data Sources Partners Other Functional Areas • Cloud R&D Platform Unified Safety System
- 15. 15 Copyright © Veeva Systems 2021 Traditional ICSR Reporting Process Reporting & Metrics Processing Intake Submissions Gateway Local Reporting Business Objects – Case Management Cognos, Qlik – Metrics & user reporting Receipt & Triage Reconciliation Log & Track Safety Support Issues Japanese Safety Database Safety Database Dictionary & Coding Management Safety Database Copy Literature Assessment Follow-up Letters, Clinical Queries & Tracking Aggregate Reporting
- 16. 16 Copyright © Veeva Systems 2021 Modern ICSR Reporting Process Reporting & Metrics Case Review Intake & Processing Submissions Gateway Global Reporting Metrics & O Metrics & user reporting Receipt, Triage, Data Entry Safety Database Follow-up Letters, Clinical Queries & Tracking Aggregate Reporting QC & Med Review, Submission Multilingual Multilingual Local Reporting Dictionary & Coding Management CAPA Tracking
- 17. 17 Copyright © Veeva Systems 2021 Modern ICSR Reporting Process - Identify and Review Late Submissions
- 18. 18 Copyright © Veeva Systems 2021 Modern ICSR Reporting Process - Analyze Late Submissions
- 19. 19 Copyright © Veeva Systems 2021 Integrated with clinical, regulatory and quality systems Accessible from anywhere and with any device One source of the truth Advanced automation and intelligence Unified Accessible Integrated AI Cloud Always current with regulations and new technologies Power of a Unified Solution Seamless Management of your Data & Content
- 20. 20 Copyright © Veeva Systems 2021 Cloud Always current with regulations and new technologies AI and AUTOMATION DATA ANALYSIS CONTENT Case Processing Reporting Submissions Signal Detection & Analysis Risk Management Content Management Process Management Intake Data Entry Follow-up Unified Solution - PV Process Transformation
- 21. 21 Copyright © Veeva Systems 2021 Benefits to the Industry Technology Enabled Simplified ICSR Reporting Simplified IT system Landscape Adaptive and Scalable Process Optimization and Efficiency Enhanced Collaboration and Safety Content Management Support Global and Regional Reporting
- 22. Questions
- 23. Thank you • Mike Kruczek • Director, Vault Safety Strategy • Mike.Kruczek@veeva.com • (586) 216-8105 • Saba Darvesh • Sr. Director, Vault Safety Strategy • Saba.Darvesh@veeva.com • (646) 463-2919