Call for expression of interest – Data Standards Strategy survey and workshop

The Big Data Steering Group has launched an initiative to develop a Data Standards Strategy that will enable the Network to more effectively leverage data to deliver evidence in support of benefit-risk decision-making on the development, authorisation and use of medicines.  If you are part of Patients’ & Healthcare Professionals’ organisations or a Learned Societies, the European…

EMA Training Webinars for use of CTIS

The way clinical trials are conducted in the EU will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and…