Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)

Document information
Reference	EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
Validity area	EU
Scope(s)	NIS
Document name	GVP: Module VIII EMA/813938/2011
Version / Revision	Rev. 3 (2017)
Status	Current
Document type	Official guideline
Language(s)	EN
Description	Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3)
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

References

Reference	Scope	Document part	Language	Preview
Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -	NIS	-	EN	[...] VIII.B.3. Study protocol [...] VIII.B.3.1. Format and content of the study protocol [...]
Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1	NIS	VIII.B.4.3.1	EN	VIII.B.4.3. Study reports VIII.B.4.3.1. Progress report and interim report of study results The progress report is meant to include relevant information to document the progress of the study, for ...
Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3	NIS	VIII.B.4.3	EN	VIII.B.4.3. Study reports [...] VIII.B.4.3.2. Final study report [...]
Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5	NIS	VIII.B.5	EN	VIII.B.5. Publication of study results For studies that are fully or partially conducted by investigators who are not employees of the marketing authorisation holder, the marketing authorisation ...