Introduction to this course: 

This course explores the journey of a new medicinal product from the lab to patient authorization in the EU. Learn the six-step process, submission requirements, and marketing authorization essentials.

Who should attend: 

Pharmaceutical professionals, regulatory affairs specialists, biotech researchers, and anyone involved in drug development and approval processes.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify the six steps of the EU drug authorization process.

• Implement good clinical practices in clinical trials.

What will I gain: 

Participants will gain a thorough understanding of the EU's centralized drug approval process and the ability to navigate regulatory requirements effectively.

Prerequisites: 

Basic knowledge of pharmaceutical development and regulatory frameworks is recommended.

Additional information: 

Course duration: 00:16:29

Course code/version (effective date): L-153/v1.0 (2/04/2024)