Risk assessment

Risk assessment is one of the three pillars of risk management (together with safety specifications and the risk minimisation plan). It contains both routine and additional pharmacovigilance activities to characterise the safety profile of the medicinal product including what is known and not known. It does NOT include actions intended to reduce, prevent or mitigate risks.

Glossary: Post Authorisation Safety Study [PASS]
Glossary: Safety Pharmacology
Glossary: Benefit-risk assessment
Galenic formulation: How medicines are formulated
Galenic formulation deals with the principles of preparing and compounding active ingredients into ready-to-use medicines in order to optimise their absorption by the body.
The predictive value of non-clinical testing
Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.

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