Clinical Trials Innovation
A modern Clinical Trial (CT) ecosystem for Europe, at the forefront of the ecosystem globally should consist of two key components:
1) clinical trials that use fit-for-purpose innovation, are patient, care giver and site centric and support efficient decision-making (i.e. regulatory, ethics, HTA, clinical decisions, depending on their objective);
2) an efficient and risk based regulatory ecosystem that enables patients and HCPs to identify the right trials for them and purposeful transparency provisions. This track will cover both these components, provide a status update and have critical discussions on where we want to go to continue to build a modern CTs ecosystem in Europe. The sessions should be based on concrete case studies, identify gaps and opportunities, and through thought-provoking multistakeholder discussions, identify with the audience the best path towards an attractive European CT ecosyst em that incentivises faster, smarter and more patient centric Clinical Trials.
Who is This Track Designed For?
Professionals involved and/or interested in Clinical Trials Design & Operations:- Regulatory Authorities, Ethics Committees, HTA bodies and payers.
- Commercial and non-commercial sponsors.
- Industry: Regulatory Policy, Regulatory Affairs professionals, Clinical sciences, clinical operations and biostatistics.
- ROs, service providers.
- Patients, carers and HCP representatives.
- Any other stakeholders involved in clinical research.
Topic Leader
Monique Al
Special advisor CCMO
Central Committee on Research Involving Human Subjects, Netherlands
Lada Leyens
Senior Director, EUCAN regulatory head GI
Takeda, Switzerland