Clinical Trial Regulation Conference 2016

Topics

• What are the impacts on how a clinical trial is managed after approval has been granted?
• How will the new legislation change the processes and the format of the trial application?
• How will the new provisions for public access to an EU Clinical Trials Database enforce disclosure of clinical trial data and information?
• What are the critical issues affecting sponsors and Member States as they consider changes needed to implement the regulation?

Who should Attend

• Monitors, auditors of clinical trials
• Staff from clinical science and clinical operations
• Pharmacovigilance staff
• Regulatory affairs personnel