It’s a pretty common knowledge that clinical phase of drugs or medical device development is an expensive project. From drug development to medicinal product dossier submission to EMA or FDA, through investigative sites’ costs or implementation of IT solutions, the average product can mop up the millions of dollars by...
On July 31, 2021, the European Commission announced the full functionality of the EU portal and database, the Clinical Trials Information System (CTIS) in the Official Journal of the European Union. The CTIS is inextricably linked with the Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. The EU...
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...