Non- interventional PASS studies
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what are the PV obligations for the adverse events that originate from a non interventional PASS studies. For ex if a PASS study is examining only AESI and lack of efficacy in the study then other events from this study would be reported to competent authorities just like spontaneous cases or not? What reporting time lines would be followed ? Clinical trial or postmarketing
Please refer to Guideline on good pharmacovigilance practices (GVP) Module VIII – Post - authorization safety studies (Rev 1) and Guideline on good pharmacovigilance practices (GVP) –Module VI – Management and reporting of adverse reactions to medicinal products.