Purpose of the course
The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background. This online course will provide you with a clear and concise understanding of the role played by regulatory affairs in obtaining and maintaining Marketing Authorisations for pharmaceutical 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.
This is a fully interactive eLearning course that has been developed in association with tutors from the course who have many years of regulatory experience and are currently working in the industry. It consists of two interlinked websites, 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.
You will leave the course with a better understanding of the regulatory process and your role within it.
The course is divided into five modules. You can work through the each module at your own pace, but as a guide each module should take approximately 40 minutes to complete.
Course modules:
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What is Regulatory Affairs?
- Regulatory control of clinical trials
- Marketing Authorisation Applications
- European application procedures
- Post-Authorisation activity
What you will learn
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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
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Variations
How to register
- Sign in to this website, or create an account
- Click 'Register myself'
- Go to your basket and pay for the course
- TOPRA will email you full instructions
Frequently asked questions
How long will the course take?
You have 183 days access to this course, during this time you can complete the course at your own pace. You can exit the course at any point and all of your answers will have been automatically saved.
If the course is not accessed within 12 months of purchase, the course access will expire and you will not be entitled to a refund.
What do I have to do to complete the course?
To complete the course you must go through each topic and answer a selection of questions. Once you have completed the course you will receive a completion certificate.
How many CPD hours will I receive?
We recommend that this course should take you 5 hours to complete, you will therefore receive 5 CPD hours upon completion.
Terms & conditions
Please read the training terms and conditions before booking onto this course. By booking a place on this course you are agreeing to the training terms and conditions
Registration fee: £340.00+VAT