post-authorisation safety study
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- 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.
- Abbreviation for
- PASS
- Broader Term
- pharmaceutical research
- Related Term
- clinical trial
- non-interventional clinical study
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