21/09/2023
Let’s dive into something that's reshaping the landscape of the pharmaceutical industry: Big Data.Big Data isn't just a trend; it's a revolution. Imagine vast amounts of data from clinical trials, patient records, genomi
10/02/2023
In clinical trials there may be added risk to the subjects compared to patients treated with authorised medicinal products.Investigational medicinal products are therefore manufactured by applying manufacturing practice which ensu
03/02/2023
The new Clinical Trials Regulation (Regulation (EU) No 536/2014) entered into application on 31 January 2022, repealing the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in
20/01/2023
Marketing Authorisation Holders (MAHs) are required to monitor scientific and medical literature and to report individual cases of suspected adverse reactions for medicinal products, for which they hold a Marketing Authorisation i
21/12/2022
EudraVigilance is the centralized European database of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA). It is used by national competen