Online Basics of European Regulatory Affairs

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ONLINE FOUNDATION COURSE

The first Online Foundation course for very new recruits, PAs, administrators, support staff, agency staff and students in Regulatory Affairs and other related areas such as Pharmaceutical, Medical Device, Manufacturing, Marketing and other companies.

The purpose of the course

The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background. The purpose of this ‘Online Basics’ course is to provide you with a clear and concise understanding of the role played by Regulatory Affairs in obtaining and maintaining Marketing Authorisations for pharmaceutical and medical device products.

Why Online

The aim of this programme is to make the course more accessible for new recruits to the industry outside of the UK, helping TOPRA meet its increasing demand for the course around the globe whilst providing a different mode of learning for the new Regulatory Professionals of today. The course is designed to allow you to study at your own pace, in your own time and more importantly at your own home or office without having to travel to attend the course.

The Online course

This is a fully interactive eLearning course that has been developed in association with tutors from the course who have many years of Regulatory Affairs experience and are currently working in the industry. It consists of two interlinked websites, comprising of a Learning Centre and a Resource Centre, which facilitates a variety of learning styles, encouraging the learner to define what they want to learn and how.

Our promise

We guarantee you will leave the course with a better understanding of the regulatory process and your role within it.

What you will learn through the programme

  • Regulatory Affairs: what is it and why is it needed?
  • The role of the Regulatory Affairs Professional within the company
  • The role of the Regulatory Affairs Professional – working with external Regulatory agencies and other bodies
  • The European legislative framework
  • How pharmaceuticals are controlled
  • The contents of a basic application dossier
  • Basic data requirements
  • Overview of drug development
  • Overview of clinical trials
  • Marketing Authorisation Applications
  • European procedures
  • Post licensing
  • Labels and leaflets
  • Variations

All of this information has been divided up into five modules of learning, and has been developed to allow the learner to work through the course at their own pace via their own computer terminal, the modules are;

  • What is Regulatory Affairs?
  • Regulatory control of clinical trials
  • Marketing Authorisation Applications
  • European application procedures
  • Post Authorisation activity

Access

Taking up the course will be by payment and auto registration via the TOPRA website.

Price

£340 + VAT

If you would like to see how this course works, please have a look at our demo.