Summary

Module 2

This module will provide you with a solid basis for evaluating the opportunities and consequences related to different types of products and submissions. It will also teach you how to plan and operate within the framework of the various application procedures.

While Module 1, "The Pharmaceutical Law Frameworks in the EU", provides you with knowledge of the pharmaceutical legislation in the EU, Module 2 focuses on the implementation of this legislation, e.g., on the procedural and operational aspects when applying for marketing authorizations, clinical trials and orphan drug designations in the EU. You will also learn how to comply with the EU requirements for pediatric investigation plans and risk management plans as well as how to obtain scientific advice from EU authorities.

Other course participants say

“Course content, speakers and organisation met my expectations, in some cases even exceeded them. I highly recommend this course". 

Dr. Kristina Mueller, Preclinical Expert. 

"I appreciated getting the general overview of European issues in a structured manner - and then presented by knowledgeable and experienced lectures. It was directly applicable, but also useful for more general discussions in and around Regulatory Affairs."

Rasmus Ploug Winchler Larsen, Senior Manager, RA CMC Biologics, LEO Pharma A/S

Keywords

• Regulatory Affairs in the EU
• Marketing Authorization Applications
• Scientific Advice
• Post-Approval Activities
• Pediatric Procedures
• Clinical Trials Applications
• Risk Management
• Orphan Medicinal Products

Please note

As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.