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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25 - 26 Mar 2025

or

11 - 12 Sep 2025

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On location

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English

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13,900 DKK ex VAT

(app. 1,869 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

This two day 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.


Other course participants say

"The course provided a comprehensive overview with a good level of details to introduce Regulatory Affairs and also useful practical guidance. Good speakers."

Anna-Karin Lindqvist, PhD, Director Project Management


"I gained a lot of context to my current taks and a holistic insight to Regulatory overall."

Rasmus Ploug Winchler Larsen, Senior Manager, RA CMC Products, Leo Pharma A/S

"As someone new in the field, I think the course provided a good overview. It was well-structured, and I got a great outcome in terms of knowledge of Regulatory Affairs and the different tasks and procedures involved. I liked that the course consisted of both lectures, case-work and quizzes."

Associate Global Regulatory Affairs Manager


"Skilled speakers with practical experience, Illustrations of real-world scenarios made the topics tangible, despite the course's high academic level."

Kirsten Berger, Global Labeling Strategy Lead, Swedish Orphan Biovitrum


"The course is informative, well-structured, and gives a good basic knowledge."

Stine Kiær Larsen, RA CMC Specialist, Novo Nordisk A/S


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

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Course leader & lecturers

  • Helen Shennan
    Course leader
    Regulatory Affairs Director
    AstraZeneca A/S
  • Margrethe Erbou Andersen
    Course leader
    Head of Regulatory Affairs Denmark
    PharmaRelations ApS
  • Mette Due Theilade Thomsen
    Lecturer
    Managing Director
    PIP Adviser
  • Eva Bøge
    Lecturer
    Regulatory Project Manager
    Zealand Pharma A/S
  • Hanne Brokopp
    Lecturer
    NDA Principal Consultant
    NDA Group, Luxembourg
  • Anette Hjelmsmark
    Lecturer
    Senior Regulatory Intelligence Manager
    Novo Nordisk A/S
  • Christina Balslev Rindshøj
    Lecturer
    VP, Head of Regulatory Affairs
    Zealand Pharma A/S
  • Mette Maegaard Sonne
    Lecturer
    Director
    Ferring Pharmaceuticals A/S
  • Mette Stie Kallesøe
    Lecturer
    Head of Pharmacovigilance QPPV
    Hansa Biopharma AB
See all

Watch the video

Is this course for you?

This course is for you if you are new to Regulatory Affairs and work in the industry, a regulatory institution, or a consulting firm.

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

Course calendar

Choose your starting date
Starting 25 Mar 2025
Starting 11 Sep 2025
25 Mar 2025 8:30-16:30
Day 1
  • Welcome and introduction to the course program
  • Role of the regulatory affairs
  • Product information
  • EU institutions and legal framework for medicinal products
  • Types of medicinal products and what kind of documentation are needed for registration
  • Registration of medicinal products in the EU
  • Maintenance of a marketing authorization
  • Workshop
26 Mar 2025 8:30-16:00
Day 2
  • Summary of day 1
  • Regulatory – clinical aspects
  • Pharmacovigilance
  • eCTD – Organising Data
  • Workshop
  • Drug registration in the US
  • Summing up and goodbye
Practical information

Registration

Registration deadline
18 Mar 2025
Atrium
Lersø Parkallé 101
2100 København Ø
Register
25 - 26 Mar
11 Sep 2025 8:30-16:30
Day 1
  • Welcome and introduction to the course program
  • Role of the regulatory affairs
  • Product information
  • EU institutions and legal framework for medicinal products
  • Types of medicinal products and what kind of documentation are needed for registration
  • Registration of medicinal products in the EU
  • Maintenance of a marketing authorization
  • Workshop
12 Sep 2025 8:15-16:00
Day 2
  • Summary of day 1
  • Regulatory – clinical aspects
  • Pharmacovigilance
  • eCTD – Organising Data
  • Workshop
  • Drug registration in the US
  • Summing up and goodbye
Practical information

Registration

Registration deadline
4 Sep 2025
Atrium
Lersø Parkallé 101
2100 København Ø
Register
11 - 12 Sep
Sometimes things change. This is the expected programme.

Course information

Literature

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

Please familiarize yourself with the mandatory readings before starting the course.

Examination

There is no examination for this course.

Course leaders

Helen Shennan
Regulatory Affairs Director
AstraZeneca A/S
Margrethe Erbou Andersen
Head of Regulatory Affairs Denmark
PharmaRelations ApS

Lecturers

Mette Due Theilade Thomsen
Managing Director
PIP Adviser
Helen Shennan
Regulatory Affairs Director
AstraZeneca A/S
Eva Bøge
Regulatory Project Manager
Zealand Pharma A/S
Hanne Brokopp
NDA Principal Consultant
NDA Group, Luxembourg
Anette Hjelmsmark
Senior Regulatory Intelligence Manager
Novo Nordisk A/S
Christina Balslev Rindshøj
VP, Head of Regulatory Affairs
Zealand Pharma A/S
Mette Maegaard Sonne
Director
Ferring Pharmaceuticals A/S
Mette Stie Kallesøe
Head of Pharmacovigilance QPPV
Hansa Biopharma AB

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Want to know more or need help?

Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

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