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Professional Training
5.0 (1 Reviews)

Fundamentals of Clinical Trial Regulations

PTI, Online
Length
4 weeks
Length
4 weeks
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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

Reviews

Average rating 5

Based on 1 reviews.
Reviews are published according to our review policy.
Write a review!
Lecturer, HRB Clinical Research Facility
5/5
23 Jun 2020
Useful and informative

Content and delivery was very good, I found this course really useful and informative.

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