Module 6

04 October 2024

Benefit-Risk Balance of a medicinal product

Directive 2004/27/EC

Article 1 – Definition of risk and risk/benefit balance

Risks: any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health (any risk of undesirable effects on the environment)

Risk/benefit balance: an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks as defined above

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An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

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Benefit-Risk Balance of a medicinal product

Assessment Template based on ProACT-URL

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Disease/Condition, Aim of therapy (indication) Available therapies and unmet need

Unmet need Risk attitude

Therapeutic context

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Main clinical studies

Importance Balance of benefits-risks

Uncertainty and limitations about the benefits Uncertainty and limitations about the risks

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e.g primary, secondary endpoints, point estimates, CI e.g severity, duration, reversibility, dose-response relationship, AE incidence leading to withdrawal and or hospitalisation Important favourable and unfavourable effects including uncertainties and limitations

Favourable effects

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Unfavourable effects

Additional considerations on the benefit-risk balance

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Effects Table

Conclusions

An Agency perspective: the success and failure of a medicinal product in the EU

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Classified as public by the European Medicines Agency

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