The Pharmaceutical Law Frameworks in the EU

Understand the pharmaceutical law frameworks and how legislation is developed in the EU

  • 17. Jun 2019
  • 4. May 2020

3 days course

English

17.650,- DKK ex VAT
(app. 2.373,- EUR ex VAT)

module 1

summary

On this course, you will gain an understanding of the background of the EU legal system and the EU legislative framework underpinning each step of the drug development process. You will learn about the roles and responsibilities of the key players in the EU regulatory process, and about collaboration between institutions. After the course, you will be able to analyze and critically appraise a medicinal product in the context of the EU legislative framework.


Keywords

Regulatory Affairs in the EU
EU Regulations and Directives
Notes for Guidance
The EU Commission
European Medicines Agency (EMA)

What you will learn

  1. The principles of the EU legislative framework underpinning each step of the drug development process from pre-approval to post-approval
  2. The roles and responsibilities of the key players in the EU regulatory process
  3. How the legislation helps establish an on-going benefit-risk evaluation throughout the life cycle of a medicinal product
  4. How to analyze and critically appraise a medicinal product in the context of the EU legislative framework
  5. How to use good regulatory practices as a means of improving the regulatory environment  

What your company will get

  1. A regulatory professional who understands the EU regulatory process and collaboration between EU institutions
  2. A regulatory professional who can provide valuable input to all other team members in projects concerning EU regulations and directives
  3. 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
All course dates: 17. Jun 2019, 18. Jun 2019, 19. Jun 2019
All course dates: 4. May 2020, 5. May 2020, 6. May 2020

When registering, you can choose the dates that suit you.

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.comRead our cancellation policy.

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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