Post-authorisation safety Any study relating to an authorised medicinal product conducted with the aim of EU Pharmacovigilance Directive 2010/84/EU studies identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures. Such studies may be aimed at collecting data to enable the assessment of safety of medicinal products in everyday medical practice (from EU Pharmacovigilance Directive).
Post-authorisation safety studies Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures. Such studies may be aimed at collecting data to enable the assessment of safety of medicinal products in everyday medical practice (from EU Pharmacovigilance Directive). EU Pharmacovigilance Directive 2010/84/EU
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