Do you fully understand the clinical trial regulations governing medical research?
Are you aware of the approval process in Europe?
Clinical trials are pivotal to the development of new therapeutic products, however 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 seven modules, this course will take you through the history of clinical trial regulations, the new Clinical Trial Regulation and best practices for ensuring a timely clinical trial authorisation. You will explore important frameworks in clinical trial regulations, including: ICH GCP, Ethics Committee Application, Clinical Trials in Children and Adverse Events reporting.
You will cement this knowledge through case studies highlighting the entire clinical trial process.
Dr Laura Brown
Dr Laura Brown is an independent training consultant. She also acts as Director of the MSc in Regulatory Affairs, TOPRA and Course Director of the MSc in Clinical Research, Cardiff University. Dr Brown is an international expert on regulatory requirements in clinical research. She was Chairman of the Institute of Clinical Research GCP Forum for six years, and writes regularly on clinical research regulatory requirements, having authored SCRIP’s latest GCP guide, and a practical guide to the Clinical Trial Directive. She is a member of the editorial board of the Good Clinical Practice Journal.
This course is applicable to persons involved, or interested in, clinical trials in the European Union.
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PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Once you have registered you will be given login details to access the course