Search results
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).
Specific quality objectives and quality requirements for the specific structures and processes of the pharmacovigilance systems are provided in each Module of GVP as appropriate. The quality system is part of the pharmacovigilance system and consists of its own structures and processes.
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:
This Module includes the principles of risk minimisation and should be read in conjunction with GVP Module XVI and GVP Module XVI Addendum I on educational materials. In this Module, all applicable legal requirements are referenced in the way explained in the GVP
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.
This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products ...
Apr 18, 2022 · Good Pharmacovigilance Practices (GVP): A Quick-Guide. If your time is short: Today, the World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.
79 GVP Modules I to XVI , the creation of this guidance as a GVP Chapter aims at integrating paediatric 80 pharmacovigilance with the structures and processes for pharmacovigilance overall. 81 P.IV therefore applies in conjunction with the GVP Modules I to XVI.
Jul 26, 2022 · The guidance on GVP is organised into two types of chapters – modules on pharmacovigilance processes, and product or population-specific considerations. The focus of the PIPA training is on the following
Objectives of the EU reference dates list. 1356 The Agency shall make public a list of Union reference dates (hereinafter referred to as list of EU 1357 reference dates) and frequency of submission of PSURs by means of the European medicines web-1358 portal [DIR Art 107c(7), REG Art 26(1)(g)].
