EMA Finalizes Pharmacovigilance Guidelines
The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices.
The European Medicines Agency (EMA) has published its first set of finalized guidelines concerning good pharmacovigilance practices (GVP). The guidelines are a key deliverable of Europe’s pharmacovigilance legislation, which will come into effect on July 2, 2012.
Several modules make up the GVP package. Seven modules have been finalized so far concerning pharmacovigilance systems and their quality systems, pharmacovigilance systems’ master files, risk-management systems, management and reporting of adverse drug reactions to medicinal products, periodic safety update reports, postauthorization safety studies, and signal management.
Each module was released for consultation between February and April 2012 and the final versions reflect some of the comments received. Each module was developed by a team of experts from the EMA and EU member states.
More modules are also under development, including modules for pharmacovigilance inspections and additional monitoring, and will be released for consultation later in the year.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
