Course description
Essentials of European Regulatory Affairs (Online 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 and medical device products.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Upcoming start dates
1 start date available
Suitability - Who should attend?
Our first online Essentials course for new recruits, PAs, administrators, support staff, agency staff and students in regulatory affairs.
Outcome / Qualification etc.
What you will learn
- 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
Once you have completed the course you will receive a completion certificate.
Training Course Content
Course modules:
- What is Regulatory Affairs?
- Regulatory control of clinical trials
- Marketing Authorisation Applications
- European application procedures
- Post-Authorisation activity
Request info
Ads