This conference will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes, including the new EU clinical trials Regulation but also conducting novel complex innovative design trials. Regulators and other decision-makers, together with various experts in the field, will debate how the new legislation will impact the processes for the design, submission and approval, and managing European clinical trials in the future.
• Status of the CTR
• Ethics Committee preparedness for CTR
• Update on national pilots from MS
• Innovative Trial Designs and their Management
• GDPR and its consequences for Clinical Trials
• Member States preparedness for the regulation, including plans for co-operation between agencies and ethics committees and coordinated assessment
• Considerations for the preparation of applications and notifications by sponsors