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Module VIII – Post-authorisation safety studies (Rev 3) - Updates in VIII.B.3.1. (study protocol section 11), VIII.B.4.2. and XIII.B.4.3.2. (final study report section 10.6.), in order to align this Module with revision 2 of GVP Module VI.
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.
Module VIII, in B.2., also states that marketing authorisation holders should register all non- interventional PASS conducted voluntarily in the EU or included in the risk management plan (RMP) agreed in the EU.
This document provides guidance on conducting post-authorization safety studies (PASS) in Europe, including legal requirements and best practices. It describes PASS as studies of authorized medicines aimed at identifying, characterizing, or quantifying safety hazards.
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The empty ovarian follicle that secretes progesterone after release of the egg cell is called the: Question 8 options: 1) fimbriae 2) chorion 3) corpus luteum 4) uterine serosa
A sigmoidoscopy is the endoscopic examination of the interior of the rectum, sigmoid colon, and possibly a portion of the descending colon. anti-, emet, -ic. An antiemetic is a medication that is administered to prevent or relieve nausea and vomiting. gastr/o, duoden, -osotomy.
