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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.
CONNECT WITH...
- Regulatory agencies (assessors, reviewers, inspectors)
- Regulatory affairs personnel in clinical research
- Professionals in charge of clinical trial strategy
- Regulatory intelligence and policy professionals
- Change managers for clinical trials business processes
- Clinical research professionals working with submission, data, information sharing
- Clinical safety professionals
….and many more!