Introduction to Regulatory Affairs

Learn about the many tasks of a regulatory affairs department and how to obtain and maintain a marketing authorization in Europe

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  • 26. Apr 2021
  • 28. Oct 2021

2 days course

English

8.870,- DKK ex VAT
(app. 1.193,- EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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Summary

This course will give you a thorough introduction to the many tasks of a regulatory affairs department throughout the product life cycle of a pharmaceutical product — from early clinical trials and submission of a marketing authorization application to the life cycle management activities. You will learn about the EU procedures for obtaining marketing authorizations for pharmaceutical products, the documentation required in support of an application and many other tasks of a regulatory affairs department as well as the regulatory legislation.

Our course will focus on the European Union (EU) and give a brief introduction to the regulatory framework in the US.

Keywords

  • Regulatory Affairs
  • EU Legal Framework for Medicinal Products
  • Documentation and Registration
  • Maintenance of a Marketing Authorization
  • Clinical Trials
  • eCTD
  • Product Information
  • Pharmacovigilance
  • Quality
  • Drug Registration in the US

Course calendar

Start 26. Apr 2021
Registration deadline 29. Mar 2021
26. Apr 20218:15 - 16:45
27. Apr 20218:00 - 16:45
Start 28. Oct 2021
Registration deadline 30. Sep 2021
28. Oct 20219:00 - 16:00
29. Oct 20219:00 - 16:00
Atrium
Lersø Parkallé 101
2100 København Ø

What you will learn

 

  1. The EU regulatory legislation
  2. How to obtain and maintain a marketing authorization in Europe
  3. The documentation required in support an application in Europe
  4. The many tasks of the regulatory affairs department

What your company will get

 

  1. An employee who understands the many tasks of the regulatory affairs department
  2. An employee who will quickly get the necessary overview of the regulatory affairs area and be able to take action, e.g., in a new role
  3. An employee who can act as a sparring partner to colleagues in regulatory affairs
  4. An employee who can provide better and more qualified support to colleagues in regulatory affairs
Available start dates
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Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send an email

 

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