EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter

The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS. Read more “EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter”

The latest MHRA guidance surrounding clinical trials and Brexit

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released their latest guidance on conducting clinical trials for investigational medicinal products (IMP) after the transition period. It sets out requirements for the registration, publication of summary results and amendments to clinical trials, as well as submitting clinical trial safety reports. Read more “The latest MHRA guidance surrounding clinical trials and Brexit”