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ICH E8 (R1)  has been adopted since 2020. Are you ready to focus on good process design and risk management? To quote from the draft regulation: "Quality should rely on good design and its execution rather than overreliance on retrospective document checking, monitoring, auditing or inspection."

In this one day virtual course, we explore important concepts from ICH E8 (R1) such as "errors that matter", "Quality by Design" and "Critical Thinking". Topics include how to map processes to look for improvement opportunities and help people understand them better, how to assess and control risk in alignment with ICH E6 (R2), the intricacies of defining effective metrics and their use (and mis-use!), and using data to understand and improve processes. 

Join us to learn about these topics, share experiences and challenges in process improvement and measurement in clinical trials and explore realistic strategies to help your organization focus on process and risk as part of your strategy to become compliant with ICH E8 (R1). If you’re interested, contact the Institute to book for the next available date.

This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP. 

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook.

Medical Devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. There are over 300 000 types of medical devices on the EU market, examples of which include sticking plasters, contact lenses, X-ray machines, pacemakers, breast implants, software apps and hip replacements. The medical devices sector is essential to the provision of healthcare and is an important player in both the European and global economy.

Released in 2020 the updated ISO14155 standard, which addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices, has been significantly revised.

Approximately 1.5 million different medical devices are available globally; with thousands of new and innovative medical devices being introduced to the market every year. While there is legislation at the national and regional level ISO 14155 provides a global standard for clinical investigations on human subjects.

Please note: ISO 14155 is only applicable for Medical Devices including diagnostic/imaging devices BUT NOT In Vitro diagnostics (IVD).

Statistics is the art and science of summarising data.  Statistics play an essential role in all stages of clinical research from design through to analysis and interpretation. 

Clinical Trials generate large volumes of data but most of us are looking for the “punch-line”;  Did the new treatment work?  Were the two groups being compared the same of different?  We rely on statistics to help us design the most appropriate trial to answer our questions, to determine the required sample size and to interpret the results.  A poorly designed study wastes time, resources and puts patients at unnecessary risk.  A solid understanding of statistical principals is important for all team members, not just the team statistician; however for many of us statistics is nearly a foreign language. 

This course is aimed at non-statisticians who work in clinical research and provides an introduction to the statistical methods used for the design, conduct and analysis of clinical trials.  The course emphasises the application of statistical concepts to clinical research; aiming to demystify the subject and equipping delegates with the knowledge to read, understand, interpret and communicate data & statistics. 

This is an introductory course and no significant mathematical knowledge is required.

Delegates should bring a laptop and calculator to the course.