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Fundamentals of Clinical Trials Regulations

4-week online academy | 2 hours per week

6 April - 8 May 2020

Online Academy

Do you fully understand the clinical trial regulations governing medical research?

In June 2016, the UK voted to leave the EU, this brought uncertainty to the clinical research industry regarding how clinical trial conduct may be affected. However, the UK & EU have reached a consensus that the UK will remain compliant with EU regulations regarding clinical research until 31st December 2020, for the sake of business continuity. Therefore, this course will provide imperative information for sponsors wishing to conduct clinical trials during this time period.

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.

Delegates will be able to cement this knowledge through case studies highlighting the entire clinical trial process.

  • Gain a well-rounded knowledge of Clinical Trial Regulations, from history to authorisation.
  • Understand how to apply for a Clinical Trial Authorisation, and explore common challenges including substantial and non-substantial amendments and insurance considerations.
  • Consolidate your knowledge using case study examples.
  • Understand the importance of ICH GCP principles in running clinical trials
  • Familiarise yourself with the ethical considerations of a clinical trial, and learn how to apply for a clinical trial registration through EudraCT

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.

Some departments may include:

  • Clinical research team
  • Clinical research agencies
  • R&D in pharmaceutical companies

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.

What the Online Academy Video

On average, delegates of our online academies said:

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