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

21 - 22 Sep 2023

or

3 - 4 Apr 2024

On location

English

13,100 DKK ex VAT

(app. 1,761 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

  • Anne Vinding Sillemann
    Course leader
    Regulatory Principal Specialist, RA Rare Endocrine Disorders
    Novo Nordisk A/S
  • Anette Hjelmsmark
    Lecturer
    Senior Regulatory Intelligence Manager
    Novo Nordisk A/S
  • Eva Bøge
    Lecturer
    Regulatory Project Manager
    Zealand Pharma A/S
  • Hanne Brokopp
    Lecturer
    NDA Principal Consultant
    NDA Group, Luxembourg
  • Helen Shennan
    Lecturer
    Regulatory Affairs Director
    AstraZeneca A/S
  • Mette Due Theilade Thomsen
    Lecturer
    Managing Director
    PIP Adviser
  • Mette Maegaard Sonne
    Lecturer
    Director
    Ferring Pharmaceuticals A/S
  • Mette Stie Kallesøe
    Lecturer
    Senior Principal Professional, Deputy QPPV
    LEO Pharma A/S
  • Christina Balslev Rindshøj
    Lecturer
    Senior Director
    Ozack ApS
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 21 Sep 2023
Starting 3 Apr 2024
Starting 11 Sep 2024
21 Sep 2023 8:15-16:00

Day 1

  • The role of regulatory affairs
  • EU institutions and legal framework for medicinal products
  • Types of medicinal products and documentation that is needed for registration
  • Registration of medicinal products in EU
  • Maintenance of a marketing authorization
  • Workshop
22 Sep 2023 8:15-16:30

Day 2

  • Product information
  • Quality - Seen from a Regulatory Affairs perspective
  • Regulatory - Clinical aspects
  • Pharmacovigilance
  • eCTD
  • Drug registration in the US
  • Workshop
Practical information

Registration

Registration deadline
24 Aug 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
21 - 22 Sep
3 Apr 2024 9:00-16:00

Day 1

  • The role of regulatory affairs
  • EU institutions and legal framework for medicinal products
  • Types of medicinal products and documentation that is needed for registration
  • Registration of medicinal products in EU
  • Maintenance of a marketing authorization
  • Workshop
4 Apr 2024 9:00-16:00

Day 2

  • Product information
  • Quality - Seen from a Regulatory Affairs perspective
  • Regulatory - Clinical aspects
  • Pharmacovigilance
  • eCTD
  • Drug registration in the US
  • Workshop
Practical information

Registration

Registration deadline
27 Mar 2024
Atrium
Lersø Parkallé 101
2100 København Ø
Register
3 - 4 Apr
11 Sep 2024 9:00-16:00

Day 1

  • The role of regulatory affairs
  • EU institutions and legal framework for medicinal products
  • Types of medicinal products and documentation that is needed for registration
  • Registration of medicinal products in EU
  • Maintenance of a marketing authorization
  • Workshop
12 Sep 2024 9:00-16:00

Day 2

  • Product information
  • Quality - Seen from a Regulatory Affairs perspective
  • Regulatory - Clinical aspects
  • Pharmacovigilance
  • eCTD
  • Drug registration in the US
  • Workshop
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

Anne Vinding Sillemann
Regulatory Principal Specialist, RA Rare Endocrine Disorders
Novo Nordisk A/S

Lecturers

Anette Hjelmsmark
Senior Regulatory Intelligence Manager
Novo Nordisk A/S
Eva Bøge
Regulatory Project Manager
Zealand Pharma A/S
Hanne Brokopp
NDA Principal Consultant
NDA Group, Luxembourg
Helen Shennan
Regulatory Affairs Director
AstraZeneca A/S
Mette Due Theilade Thomsen
Managing Director
PIP Adviser
Mette Maegaard Sonne
Director
Ferring Pharmaceuticals A/S
Mette Stie Kallesøe
Senior Principal Professional, Deputy QPPV
LEO Pharma A/S
Christina Balslev Rindshøj
Senior Director
Ozack ApS

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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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