The objective of a drug treatment is to deliver specific benefits to the patient. However, no drug is devoid of risk. Effective risk management ensures that expected benefits outweigh any risks of a medicinal product. The concept of risk minimisation is not new but it is evolving rapidly and innovative solutions are expected to emerge in the near future. This document summarises two recent documents published by the Council for International Organizations of Medical Sciences (CIOMS) (1) and the European Medicines Agency (2).

They provide guidance on risk minimisation strategies and share the common goal of achieving a positive risk benefit balance.

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