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Human regulatory: overview. Post-authorisation. Pharmacovigilance: post-authorisation. Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU).
The European Medicines Agency developed the good-pharmacovigilance-practice (GVP) guideline to facilitate the performance of pharmacovigilance activities in the European Union. GVP is a key deliverable of the 2010 pharmacovigilance legislation to replace earlier guidance drawn up by the European Commission.
- Transfer of the guidance on emerging safety issue to GVP Module IX; - Editorial amendments to align the format with other GVP Modules.
Mar 30, 2023 · Discover the essentials of good pharmacovigilance practice with our comprehensive guide to EMA GVP modules. Learn about monitoring medicines safely, complying with regulations, and ensuring patient safety.
Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 1) Draft finalised by the Agency in collaboration with Member States and
This new guidance on good pharmacovigilance practices (GVP) is organised into two types of chapters, namely Modules on pharmacovigilance processes and Product- or Population-Specific Considerations.
There are 12 GVP modules labeled I to XVI, which cover major pharmacovigilance processes. (Module numbers XI, XII, XIII and XIV are null since the EMA already addressed their planned topics in other guidance documents.) Let’s look at each module and see how they play a part in keeping patients safe:
17 - Editorial amendments to align the format with other GVP Modules . 18 . Comments should be provided using this . template. The completed comments form should be sent to gvp@ema.europa.eu 19 Note for public consultation : 20 The public consultation is restricted to the revised texts or deleted texts highlighted in “track changes” 21 mode. However, if revisions or deletions impact or contradict other existing text s, comments on such
Guideline on good pharmacovigilance practices (GVP) – Module VII (Rev 1) EMA/816292/2011 Rev 1 – Track-change version following pu blic consultation Page 4/72 . 125 VII.C.5.1. PSUR EU regional appendix, sub-section “Proposed product information” ..... 61 126 VII.C.5.2. PSUR EU regional appendix, sub-section “Proposed additional pharmacovigilance
process-related GVP Modules when developing and implementing pharmacovigilance for biologicals to ensure that these challenges are addressed. P.II.A. describes some of the specific issues and
