Introduction to this course: 

This course covers the European Marketing Authorization Application process for new medicinal products. Learn all application types, submission requirements, and evaluation procedures to ensure new medicinal products meet regulatory standards.

Who should attend: 

This course is designed for regulatory affairs professionals, pharmaceutical project managers, clinical research coordinators, and anyone involved in the drug development and marketing authorization process.

Learning Outcomes: 

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

• Identify key terms and procedures in the European Marketing Authorization process.

• Explain the different types of marketing authorization applications and their specific requirements.

What will I gain: 

Participants will gain a clear understanding of the European Marketing Authorization process and gain the skills to prepare and submit a complete application dossier in the EU.

Prerequisites: 

Prerequisites for this course are having a basic understanding of pharmaceutical development and regulatory affairs. Experience in clinical trials or drug development is beneficial but not mandatory.

Additional information: 

Course duration: 00:18:44

Course code/version (effective date): L-155/v1.0 (3/04/2024)