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
01/09/2022
Clinical trials in human medicines are studies carried out in human volunteers intended to investigate the safety or efficacy of one or more investigational medicines.Clinical trials can only be started after a compound has passed