Understanding EU Clinical Trials Regulation No 536/2014
Learn about the Clinical Trial Applications (CTAs) in the EU/EEA and how to maneuver the Clinical Trials Information System (CTIS).
What you are going to learn
Improved public information on clinical trials & results through Clinical Trial Information System (CTIS)
The Clinical Trials Regulation (EU) no 536/2014 came into effect on 31 January 2022. Learn about the regulation and how clinical trial sponsors, patient advocates, and patients can interact with the public website.
Throughout this course you will learn:
- Evolution of the legal framework for clinical trials in EU/EEAT
- The Clinical Trials Information System (CTIS)
- The key changes resulting from the Clinical Trials Regulation (CTR)
- Patient engagement within the CTR and CTIS
- Navigating the CTIS public website
European Medicines Agency
Laura qualified as pharmacist and obtained a master in pharmacovigilance before joining the EMA in 2009 in the Inspection Department, where she was responsible for GCP and Pharmacovigilance inspections requested by the Agency.
Since 2017 she has been working on the development of the Clinical Trial Information System, defining and testing the system functionalities in collaboration with the European Commission , the Member States and sponsors product owners.
As part of the CTIS development, Laura has been leading on the data protection aspects and has been actively involved in the training and dissemination of knowledge on system functionalities to the CTIS users community.