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Informa
Starting 14 September 2020

4-week online academy

Adopt best practices and ensure a quick turnaround on clinical trial authorisation

Course Overview

Do you fully understand the clinical trial regulations governing medical research?  
 
Are you aware of the approval process in Europe?  
 
Clinical trials are pivotal to the development of new therapeutic products, however, to ensure patient safety they must comply with strict regulations and approval processes. The Clinical Trial Regulation in Europe has created a simpler system to navigate multi-Member state trials in terms of approval and reporting.  
 
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.
 
You will cement this knowledge through case studies highlighting the entire clinical trial process.

Online Academies

PTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 4 weeks students will learn through:

  • 7 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Clinical Trial Regulations
Clinical Trial Regulations

Gain a well-rounded knowledge of clinical trial regulations, from history to authorisation

Clinical Trial Authorisation
Clinical Trial Authorisation

Understand how to apply for a Clinical Trial Authorisation, and explore common challenges including substantial and non-substantial amendments and insurance considerations


ICH GCP
ICH GCP

Understand the importance of ICH GCP principles in running clinical trials

Ethical Considerations
Ethical Considerations

Familiarise yourself with the ethical considerations of a clinical trial, and learn how to apply for a clinical trial registration through EudraCT

Who is this course for?

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

Find out more about online academies...


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.

On average, delegates of our online academies said...

4/5
for quality of content
85%
applied content during the course to their role
4/5
for quality of delivery

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.