Guideline on good pharmacovigilance practices (GVP) - Product- or Population-Specific Considerations I Vaccines for prophylaxis against infectious diseases

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases

Revised draft agreed by ERMS FG 11 November 2013 Revised draft adopted by Executive Director as final 9 December 2013 Date for coming into effect after finalisation 13 December 2013 6 This track-change version identifies the majority of changes introduced to the public consultation version of this document as the Agency’s response to the comments received from the public consultation. This trac...

Guideline on good pharmacovigilance practices (GVP) Module IX Addendum I – Methodological Aspects of Signal Detection from Spontaneous Reports of Suspected Adverse Reactions

Guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

Guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological Aspectsaspects of Signal 4 Detectionsignal detection from Spontaneous Reportsspontaneous reports of 5 Suspected Adverse Reactionssuspected adverse reactions

The quality System in Good Pharmacovigilance Practices (GVP) Good statistical practices regarding the quality control of lots applied to the cases processing

This paper shows that pharmaceutical companies and CRO often fail to respond to the recommendations of Good Pharmacovigilance Practices (GVP) by highlighting the lack of efficiency of the quality control (QC) process applied to the pharmacovigilance cases processing. The paper summarized the sampling acceptance statistical theory behind the good statistical practices regarding QC of lots and sh...