17th Annual Early Clinical Devlopment 2016 is a conference that provides knowledge on how the new clinical trial regulations will affect early phase development in Europe.
17th Annual Early Clinical Devlopment 2016 is a conference that covers topics such as:
- Adopting the new submission process: What changes will there be to enable a more streamlined approach to regulatory and ethical approval
- Outlining the differences between the current EU directive and proposed regulation
- What will be the direct impact on Phase I studies?
- Utilising this framework to speed up trial submissions, promote collaboration between smaller companies and academics
- How is the agency preparing for these changes?
- Predicted timelines for implementation in European countries
- Patient populations?
- How can patient advocacy groups open up previously inaccessible
- To aid recruiting for early phase studies?
- How can we establish a partnership between industry and patient groups
- Considered?
- What political and ethical pressures and challenges need to be
- Do we need to consider bringing the trial to the patient for orphan diseases to secure overall success?
- How can we run trials in collaboration with patient associations?