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

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EMA/813938/2011  Rev. 3 (2017)
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EMA/813938/2011
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|DocDescription=Guideline on good pharmacovigilance practices (GVP)
Module VIII – Post-authorisation safety studies (Rev 3)
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|DocSubmittedBy=Florian Adragna
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|reference=EU  GVP: Module VIII
EMA/813938/2011  Rev. 3 (2017)
|validity_area=EU
|scopes=NIS
|doc_name=GVP: Module VIII
EMA/813938/2011
|version=Rev. 3 (2017)
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|doc_type=Official guideline
|language=EN
|description=Guideline on good pharmacovigilance practices (GVP)
Module VIII – Post-authorisation safety studies (Rev 3)
|official_link=https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pdf
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== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
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| [[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 [...]
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| [[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 ...
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| [[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 [...]
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| [[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 ...
|}
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