Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)
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| 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
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| 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.4.3 | NIS | VIII.B.4.3 | EN | VIII.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.4.3.1 | 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 informati… |
| 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 auth… |
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 ... |
