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

28. Oct 2021
28. Apr 2022
3. Nov 2022

2 days course

English

8,870 DKK ex VAT
(app. 1,193 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:

“Not knowing anything about Regulatory Affairs when the course started, I now have a very good overview of how it all works.”

“The course was very informative, well-organised, and I even had fun! It contained valuable background information and practicable experience. Thank you very much for a great course! I have no further comments; it was really almost perfect!"
Angela Rödel, Associate Global Regulatory Affaris, medac GmbH, Germany

Professional and warm attitude from the course leader, Atrium staff and all speakers. Your passion for what you do was showing through the screen. That is inspiring! ”
Anna-Karin Lindqvist, PhD, Director Project Management, Camurus AB, Sweden


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

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

Read more

Course leader(s) & Lecturers

  • Helen Shennan
    Course leader
    Regulatory Affairs Director
    AstraZeneca A/S
  • Mette Due Theilade Thomsen
    Lecturer
    Managing Director
    PIP adviser
  • Anette Hjelmsmark
    Lecturer
    Senior Regulatory Intelligence Manager
    Novo Nordisk A/S
  • Hanne Brokopp
    Lecturer
    NDA Principal Consultant
    Atrium
  • Mette Maegaard Sonne
    Lecturer
    Director
    Ferring Pharmaceuticals A/S
  • Dorte Bjørn-Larsen
    Lecturer
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
  • Mette Stie Kallesøe
    Lecturer
    Principal Specialist, Inspections & Audits
    LEO Pharma A/S
  • Mie Gøde Andersen
    Lecturer
    Regulatory Affairs Specialist
    Novo Nordisk A/S
  • Eva Bøge
    Lecturer
    Senior Regulatory Project Manager
    Zealand Pharma A/S
See all

IS THIS COURSE FOR YOU?

This course is relevant for you if you are newly hired in regulatory affairs or work in a department that collaborates with the regulatory affairs department.

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 28. Oct 2021
Starting 28. Apr 2022
Starting 3. Nov 2022
28. Oct 2021 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
29. Oct 2021 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
30. Sep 2021
Atrium
Lersø Parkallé 101
2100 København Ø
28. Apr 2022 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
29. Apr 2022 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
31. Mar 2022
Atrium
Lersø Parkallé 101
2100 København Ø
3. Nov 2022 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. Nov 2022 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
6. Oct 2022
Atrium
Lersø Parkallé 101
2100 København Ø
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(s)

Helen Shennan
Regulatory Affairs Director
AstraZeneca A/S

Lecturers

Helen Shennan
Regulatory Affairs Director
AstraZeneca A/S
Mette Due Theilade Thomsen
Managing Director
PIP adviser
Anette Hjelmsmark
Senior Regulatory Intelligence Manager
Novo Nordisk A/S
Hanne Brokopp
NDA Principal Consultant
Atrium
Mette Maegaard Sonne
Director
Ferring Pharmaceuticals A/S
Dorte Bjørn-Larsen
Senior Regulatory Affairs Manager
Novo Nordisk A/S
Mette Stie Kallesøe
Principal Specialist, Inspections & Audits
LEO Pharma A/S
Mie Gøde Andersen
Regulatory Affairs Specialist
Novo Nordisk A/S
Eva Bøge
Senior Regulatory Project Manager
Zealand Pharma 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

Send me a message