Course description
Fundamentals of Clinical Trial Regulations
Do you fully understand the Clinical Trial Regulations governing medical research?
This seven-module course will take you through the history of clinical trial regulations, the current 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.
participants will be able to cement this knowledge through case studies highlighting the entire clinical trial process.
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Suitability - Who should attend?
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
Outcome / Qualification etc.
- 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
Training Course Content
- Module 1: Overview of European Regulatory Framework for Clinical Trials
- Module 2: The New EU Clinical Trial Regulation
- Module 3: Clinical Trial Authorisation – part 1
- Module 4: Clinical Trial Authorisation – part 2
- Module 5: Clinical Trials in Children
- Module 6: Investigational Medical Product
- Module 7: Regulatory Inspections, Pharmacovigilance & Adverse Events Reporting
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Content and delivery was very good, I found this course really useful and informative.