Module 2

Summary

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.

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.