21/02/2024
Hey everyone in the regulatory and pharmaceutical world!Just dropping in to share the latest scoop from EMA: they've rolled out an update of the guidance on electronic submission of information for investigational medicinal produc
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
21/09/2022
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) decided to harmonise EU position on interchangeability of biological medicines by issuing a joint statement confirming that biosimilar medicines approve
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
14/04/2022
The war in Ukraine is causing disruptions in the conduct and planning of clinical trials. Although these disruptions are most severe in Ukraine, other countries are also affected, for example due to the arrival of refugees fleeing