Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

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

From GxPlex

Jump to: navigation, search
← Older edit
m 1 revision imported
Remove static References table, superseded by live #ask in Template:DocumentData (GxPlexBot)
Β 
(8 intermediate revisions by 3 users not shown)
Line 1: Line 1:
<noinclude>{{#set:
{{DocumentData
|DocReference=EUΒ  GVP: Module VIII
EMA/813938/2011Β  Rev. 3 (2017)
|DocValidityArea=EU
|DocScopes=NIS
|DocName=GVP: Module VIII
EMA/813938/2011
|DocVersion=Rev. 3 (2017)
|DocStatus=Current
|DocType=Official guideline
|DocLanguage=EN
|DocDescription=Guideline on good pharmacovigilance practices (GVP)
Module VIII – Post-authorisation safety studies (Rev 3)
|DocRestricted=No
|DocSubmittedBy=Florian Adragna
|DocContributors=
}}</noinclude>
Β 
{{DocumentBox
|reference=EUΒ  GVP: Module VIII
|reference=EUΒ  GVP: Module VIII
EMA/813938/2011Β  Rev. 3 (2017)
EMA/813938/2011Β  Rev. 3 (2017)
Line 35: Line 17:
|contributors=
|contributors=
}}
}}
<noinclude>
== References ==
{| class="wikitable" style="width:100%;"
! 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 ...
|}
</noinclude>

Latest revision as of 14:15, 16 July 2026


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

 ScopeDocument partLanguagePreview
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

[...]…
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3NISVIII.B.4.3ENVIII.B.4.3. Study reports

[...] VIII.B.4.3.2. Final study report

[...]…
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.4.3.1NISVIII.B.4.3.1ENVIII.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 informati…
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) VIII.B.5NISVIII.B.5ENVIII.B.5. Publication of study results For studies that are fully or partially conducted by investigators who are not employees of the marketing auth…
Retrieved from "https://gxplex.org/index.php?title=Document:EU_GVP:_Module_VIII_EMA/813938/2011_Rev._3_(2017)&oldid=20337"