The EU Regulatory Environment - Procedures and Applications

EU Applications for Marketing Authorizations, Pediatric Investigation Plans, Clinical Trials and Orphan Drug Designation

  • 3. Sep 2018

3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

Course fee is DKK 17,350 + exam fee DKK 2,625 = DKK 19,975 in total. For refund of exam fee, see "Please note" below. 

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.

Course fee is DKK 17,350 + exam fee DKK 2,625 = DKK 19,975 in total. 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 Senior Programme Director Tina Jensen at tj@atriumcph.com. You must apply for a refund no later than two weeks after completion of the course.

What you will learn

  1. To understand the EU regulatory framework and the various types of applications and procedures
  2. How to evaluate the opportunities and consequences related to different types of products and submissions
  3. How to analyze the overall strategic choices for the regulatory procedures used during development, application, and maintenance of the medicinal product
  4. How to use best practices when handling various applications and procedures as well as when interacting with the European Authorities

What your company will get

  1. A regulatory professional who understands and can operate within the framework of the various application procedures in the EU
  2. A regulatory professional who can evaluate and analyze the strategic choices related to different types of submissions
  3. A regulatory professional who can provide valuable input to the regulatory procedures used during the development, application, and maintenance of the medicinal product
  4. An employee who can play an important strategic role in any project team working on obtaining a marketing authorization in the EU
Available start dates
3. Sep 2018 (Registration deadline 13. Aug 2018)

Registration quick facts for master modules

When you click the “register”-button you will get to the joint Atrium and University of Copenhagen application form. To apply for the course you must fill out the form and send in the relevant documentation. If your application is accepted you will be enrolled both at Atrium and at the University of Copenhagen and your data will be registered at both institutions.

All modules that are mandatory in the Master of Medicines Regulatory Affairs at the University of Copenhagen are paid by invoice sent from the University of Copenhagen. See the University of Copenhagen’s terms and conditions here.

All the master modules can be taken individually. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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