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PSUR as tool for signal detection

PSUR as tool for signal detection. Pauline H. Gerritsen-van Schieveen European Director Drug Safety and Pharmacovigilance. Objectives of the Presentation. To share the Astellas Pharma Europe R&D procedures for Risk Analysis in the PSUR process. PSURs as tool for signal detection.

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PSUR as tool for signal detection

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  1. PSUR as tool for signal detection Pauline H. Gerritsen-van Schieveen European Director Drug Safety and Pharmacovigilance

  2. Objectives of the Presentation • To share the Astellas Pharma Europe R&D procedures for Risk Analysis in the PSUR process

  3. PSURs as tool for signal detection • Annual review – Risk Management Process • Role of HQ • Role of local DSO

  4. PSUR analysis at Astellas Pharma Europe R&D • Yearly PSURs (rolling 5 year period) • Safety Evaluation and Review meeting one month before database lock • Safety department involved, but also Regulatory Affairs and Marketing

  5. Safety evaluation and review • Draft CIOMS II line listing • 92% of data of last year • Analysis of new cases vs previous PSUR • Analysis of most frequent AEs • Analysis of issues identified for close monitoring • Check for pregnancy data • Follow-up measures • Data cleaning, check for follow-up

  6. Role of HQ • Analysis of safety data, as part of Risk Management Process • Comparison with other data in safety database (proportional reporting ratio) • Comparison with pre-clinical data (if needed) • Analysis in comparison with competitors • Risk Assessment/RMP update • Consider need for collection of further information (other databases)

  7. Role of local DSO • No role in analysis • Important role in collection of data • If bad quality data are provided, analysis is practically impossible • If many cases are not reported, analysis will not reflect reality

  8. Signal detection • Edwards et al. • Division of cases into: • Index cases • Supportive cases • Unassessable cases

  9. Index cases • Index cases are well documented cases, where a causality assessment resulted in a possible/probable causality • Few index cases can be enough to determine a relationship between a drug and an adverse event • Supportive cases as less well documented, but causality cannot be ruled out. If there is one or more index cases, they support the signal. • Unassessable cases have insufficient information for causality assessment. They usually do not contribute to a signal. Only a large number, by far outnumbering the natural incidence can be a signal.

  10. Executive Summary • Signal generation should be performed systematically Issues and problems addressed Background information • PSURs are a regulatory requirement and have a regular cycle Proposed solution • Combine PSUR and signal generation activities • Increase the available time frame by starting before data base lock

  11. Contact details • Pauline Gerritsen-van Schieveen • European Director Drug Safety and Pharmacovigilance • EU Qualified Person for Pharmacovigilance • Pauline.Gerritsen@eu.Astellas.com • +31.71.545.58.77 • +31.653.215.727

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