Date: 14 September 2020
Time: Please visit the website for more details
Duration: 2 days
Location: Radisson Blu Edwardian Kenilworth, London
Cost: Please visit the website for more details
Clinical trials are pivotal to the development of new therapeutic products, generating the safety and efficacy data required to gain regulatory approval. They also generate the evidence required to gain reimbursement and market access. Clinical trials are essential but they are also risky - to ensure patient safety they must comply with strict regulations and approval processes. The Clinical Trial Regulation in Europe has created a simpler system to navigate multi-Member state trials in terms of approval and reporting.
Over 2 days you will examine the history of clinical trial requirements, the new Clinical Trial Regulation and best practices for ensuring a timely clinical trial authorisation. Through case studies and discussion you will explore important frameworks in clinical trial regulations, including: ICH GCP, Ethics Committee Application, Clinical Trials in Children and Adverse Events reporting.