Understanding EU Drug Regulatory Affairs
E-learning course for freshers to Drug Regulatory Affairs


Who should attend:
This course is aimed at all students, recent graduates and career changers wishing to enter the field of regulatory affairs from the following backgrounds


  • Natural scientists (biology, biochemistry, chemistry, food chemistry, etc.)
  • Pharmacists
  • Human and veterinary physicians

Description:
The course is divided into five modules. You can complete each module at your own pace.

The objective of this course is to provide an introduction to drug marketing authorisation in the EU. Participants will gain a detailed insight into the responsibilities of a Regulatory Affairs Manager and learn how a medicinal product obtains marketing authorisation. The course provides a comprehensive understanding of the principles of marketing authorisation in the EU - from the development of a medicinal product to its authorisation and lifecycle management.
An interactive quiz is used between the different topics to help learn and understand.

After completing the course, you will receive a digital certificate of attendance with details of the course content and its scope.


Requirements:
No prior knowledge of regulatory affairs is required.


Details:
  • Format: E-Learning
  • Language: English
  • Duration: The course takes approximately 3 hours to complete.
  • Price: 189 €

What is included:
  • Course script (.pdf)

Course plan

Welcome!
Guide through the course!
Key concepts
Medicinal products
Development of new medicinal products
Marketing authorisation
Post approval
Pharmacovigilance
Final quiz
Quiz
The end