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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).
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:
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.
- Transfer of the guidance on emerging safety issue to GVP Module IX; - Editorial amendments to align the format with other GVP Modules.
Further details and guidance for the submission of PSURs in the EU, including the list of Union references dates and frequency of submission are provided in Module VII “Periodic safety update report” of the guideline on good pharmacovigilance practices (GVP) and in the following questions and answers.
New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.
Apr 18, 2022 · Topics: Pharmacovigilance. Get a basic guide to Good Pharmacovigilance Practices (GVP), including the expectations among major health organizations and regulatory agencies.
162 This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and 163 Chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in
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
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
