The Pharmaceutical Legal Frameworks in the EU, module 1

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

14 - 16 May 2024

On location


18,600 DKK ex VAT

(app. 2,501 EUR ex VAT)



On this three-day course, you gain an overview and understanding of the EU legal system and the legislative frameworks underpinning each step of the drug development process.

Special focus will be on the roles and responsibilities of the key players in the EU regulatory process and on collaboration between institutions, such as the European Medicines Agency (EMA) and the National Competent Authorities (NCAs).

These insights will enable you to maneuver and operate, taking the law framework into considerations.

You will get to know about liability for medicinal products and the necessity of making a benefit-risk evaluation on an ongoing basis. You will also learn about the regulations around referrals, variations, and regulatory data protection, which is important knowledge to manage your daily regulatory assignments. Finally, you will get to know the legal framework for Orphan medicinal products, focusing on designation, authorisation, and maintenance.

Other course participants say

"When working in pharmacovigilance, it's very useful to have a good collaboration with Regulary Affairs. The course gives a good overall view of regulatory aspects and terms. "

Tina Buch, Global Pharmacovigilance Manager, Ferring Pharmaceuticals A/S

"Atrium offers an educational, well-designed, and well-organised course that provides an overview of the structure of authorities and pharmaceutical legislation"

Gregor Mandlz, Main Association of Austrian Social Security Institutions


Do you need help choosing the right course? 

We are ready to help you at +45 39 27 60 60 or 

Stay tuned with Atrium's newsletter 


  • EU legal frameworks

  • Life science laws

  • National competent authorities

  • New pharmaceutical legislation

  • EU regulations and directives

Save information for later
Read more

Course leader & lecturers

  • Gitte Dyhr
    Course leader
    Divisional Director
    H. Lundbeck A/S
  • Stine Gregers Hørsøe
    Course leader
    Specialkonsulent, Legal & international Advisor
See all

Is this course for you?

This course is for you if you want to get a better understanding of the EU legal framework. You may work in regulatory affairs in the life science industry, in a regulatory agency, or a consulting firm. You don’t need a law degree to attend, however this course is a good introduction for e.g. life science lawyers.

What you will learn

  1. The principles of the EU legislative framework.
  2. The roles and responsibilities of the key players in the EU regulatory processes.
  3. How the legislation helps establish an on-going benefit-risk evaluation throughout the life cycle of a medicinal product.
    • How to analyse and critically appraise a medicinal product in the context of the EU legislative framework.

    What your company will get

    1. A regulatory professional who understands the EU regulatory process and the collaboration between EU institutions.
    2. A regulatory professional who can provide valuable input to other team members in projects concerning EU regulations and directives.authorization in the EU.
    3. An employee who can play a central strategic role in project teams working on obtaining and maintaining a marketing.

    Course calendar

    Starting 14 May 2024
    14 May 2024 9:00-16:00

    Day 1

    • The European System for Medicinal Products: General Background to the EU and its Institutions.
    • The European system for medicinal products: EMA.
    • The European system for medicinal products: the roles and responsibilities of National Competent Authorities (NCAs).
    15 May 2024 9:00-16:00

    Day 2

    • Marketing authorization system for pharmaceuticals in the EU
    • Clinical trials
    • Clinical trials: the new regulation
    • Referrals
    • Variations
    • Regulatory data protection
    • Regulation on medicinal products for pediatric use.
    16 May 2024 9:00-16:00

    Day 3

    • Pharmacovigilance
    • Liability, labelling, and pharmacovigilance
    • Orphan medicinal products
    • Advanced therapies medicinal products (ATMP)
    Practical information

    Related exams

    17 Jun 2024 10:00-13:00
    Go to exam page


    Registration deadline
    2 Apr 2024
    Lersø Parkallé 101
    2100 København Ø
    14 - 16 May
    Sometimes things change. This is the expected programme.

    Course information


    Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.


    The exam is held online, usually 4-6 weeks after the course.

    You will receive a link with exam questions via your personal Atrium log-in. 

    In order to participate in the exam, you must have attended the course.

    You sign up and pay for the exam separately from the course, as the exam is optional.

    This course is a part of a diploma

    Diploma in Regulatory Affairs

    The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.

    Read more

    Course leaders

    Gitte Dyhr
    Divisional Director
    H. Lundbeck A/S
    Stine Gregers Hørsøe
    Specialkonsulent, Legal & international Advisor

    You may also be interested in these courses

    Want to know more or need help?

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

    Send me a message