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Fundamentals of Clinical Trial Regulations

Course summary
4 weeks
Online courses
Professional Training

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.

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:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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Average rating 5

Based on 1 reviews

Lecturer, HRB Clinical Research Facility
Content and delivery was very good, I found this course really useful and informative.
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