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

30 Apr - 1 May 2024

or

11 - 12 Sep 2024

On location

English

13,500 DKK ex VAT

(app. 1,815 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

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.


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


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

Is this course for you?

This course is for you if you are an experienced regulatory affairs professional 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 30 Apr 2024
Starting 11 Sep 2024
30 Apr 2024 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
1 May 2024 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
23 Apr 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Register
30 Apr - 1 May
11 Sep 2024 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 2024 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 2024
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 leader

Helen Shennan
Regulatory Affairs Director
AstraZeneca A/S

Lecturers

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

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Want to know more or need help?

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

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