Linkedin post 2019

Raising pharmacovigilance awareness in the #MedSafetyWeek

This week is the Annual Pharmacovigilance Week, organized by Uppsala Monitoring Center and led in Spain by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).

For one week in November, medicine regulators across the globe simultaneously share campaign materials on their social media channels, with the hashtag #MedSafetyWeek. The campaign of this year focuses on polypharmacy (which is defined as five or more medications) and the safe use of medicines in the elderly or those with complex conditions.

It has been published that currently one third of the world’s population over 75 years old take at least six medications per day, and more than one million people consume eight or more.

As a Contract Research Organization part of our work include monitoring clinical studies in which patient have a special conditions (most of them suffer chronic diseases and usually are elderly patients), therefore we need to be aware of this condition can increase the likelihood of suffer adverse drug reactions.

For more detailed information: La AEMPS celebra la #MedSafetyWeek con una campaña para sensibilizar sobre la importancia de notificar las sospechas de reacciones adversas a medicamentosmedsafetyweek

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Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).

Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health.

EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

For more information: https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database