Latin “vigilare” – to keep awake or alert, to keep watch – is usually cited as a duty of pharmacists, who have crucial role in medicine and entire health system. They are drug experts specifically trained in the drug field. Although pharmacists are the majority in the pharmacovigilance teams, they are increasingly...
One of the objectives of the Regulation No 536/2014 is to increase the transparency of clinical trials among the general public. The public access to the data of clinical trials will be guaranteed by the EU portal and database – Clinical Trials Information System (CTIS). The CTIS workspaces and system...
More than 130 years after discovering and naming of the Plasmodium parasites behind malaria, the world now has its first approved vaccine against them. Many malaria researchers have celebrated the development, but others have expressed concerns over the deployment of a vaccine that has only moderate efficacy. On 6 October,...
The process of obtaining authorization to conduct a clinical trial involves appointment of a Reporting Member State (RMS). In multinational clinical trials, at the same time as submitting the application dossier to the CTIS, a sponsor proposes one country from among MSCs for the RMS role. Depending on whether the selected MSC agrees...
