Reference:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017) -
From GxPlex
| 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 | |
| Reference Details | |
|---|---|
| Module | Module 2 — Unit 2.1.3 |
| Scope | NIS |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Post-authorisation safety study, Protocol, Requirements |
Content
[...] VIII.B.3. Study protocol [...] VIII.B.3.1. Format and content of the study protocol [...]
