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W 07: Effectively Evaluating Risk Minimization: Mitigating the Risk of Inadequate Assessments

Poster Presenter

      Steve Mayall

      • Director
      • Huron Consulting Group
        United Kingdom


To review studies conducted to evaluate the effectiveness of additional risk minimization (RM) measures in the EU.


This review analyzed EU assessments of risk minimization effectiveness: a) conducted by Pope Woodhead that are complete or have started data collection; and b) conducted by other organizations that have publically-available results identified through a literature search.


Effectiveness evaluation of additional risk minimization has been mandatory in the EU since 2012. Good Pharmacovigilance Practices (GVP) Module XVI was released in March 2014 and includes guidance on evaluation. The results of some evaluations performed under this new environment have now become available. This review of available assessments indicates significant challenges in the design and implementation of evaluation studies across EU countries. Key challenges identified included: • developing better-quality instruments for evaluation; • collecting appropriate data that have value; • navigating specific requirements of individual EU countries; • assessing outcomes of RM programs; • selecting suitable evaluation populations to reduce bias; • gaining sufficient participation due to the perceived burden of performing evaluations; • the lack of baseline, comparators (tool users vs. non-users) and benchmarking; • interpreting and acting on evaluation results.


Additional RM measures may be required for a drug to ensure patient safety and a positive benefit-risk balance. These are described in the relevant risk management plan, such as an EU-RMP or REMS. They typically include educational tools but may also have more stringent elements to assure safe use. Although this review focused on the EU environment, many of the same factors apply for assessment of REMS. Assessing the effectiveness of risk minimization is currently one of the key challenges within the risk management field. Many of these challenges could be solved through the use of innovative approaches and potential solutions are presented. As risk minimization increasingly switches from paper-based to electronic approaches which reflect the preferences of end-users, opportunities are arising for interactive web-based RM tools that incorporate real-time effectiveness evaluation.

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