18th Annual Early Clinical Devlopment 2017

18th Annual Early Clinical Devlopment 2017 is a conference that provides knowledge on how the new clinical trial regulations will affect early phase development in Europe.

Topics

• 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?