Basics of Regulatory Affairs

The purpose of the day

The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background. The purpose of this 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 products.

The course tutors

All of the tutors on this course have many years of Regulatory Affairs experience and are currently working in the industry.

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

And there will be quizzes and prizes too!

This course will give a basic grounding in a relaxed, enjoyable environment.

Our promise

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

This conference contributes 5 hours of training to your LLL (sometimes known as Continuing Professional Development) and will enhance your Regulatory Skills relevant in the areas of human and veterinary medicines.