How to Implement the EU CTR in Sponsor Organisations to Ensure Compliance: A Practical Approach

Ruxandra is a pharmacist with over 9 years of experience in Regulatory Affairs and an EMA-certified CTIS Sponsor Master Trainer. In her role as freelance regulatory consultant, she helps clinical trial sponsors navigate the complexities of clinical trial regulations, providing targeted submission strategy advice, implementation support and training on the EU Clinical Trials Regulation (EU CTR, Reg. (EU) No. 536/2014) and the CTIS portal. Ruxandra is also the Head of Regulatory Affairs and Quality Assurance at Recolony, a Swiss start-up and spin-off from the University of Zurich, where she builds and implements the regulatory strategy for developing new anticancer therapies and is responsible for the Quality Management System of the company. Prior to this, Ruxandra held the role of Regulatory Affairs Manager, Europe at Travere Therapeutics in Switzerland, coordinating the internal EU CTR implementation and advising on clinical trial submission aspects. Before joining Travere, Ruxandra worked as Senior Regulatory Scientist at Voisin Consulting Life Sciences, where she was leading clinical trial submissions in Switzerland and other European and non-European countries, also preparing and delivering trainings on the EU CTR and CTIS. During her tenure at the European Medicines Agency, Ruxandra has contributed to the development of the CTIS portal, also being involved in user testing.