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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30 Apr - 1 May 2024

or

11 - 12 Sep 2024

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On location

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English

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13,500 DKK ex VAT

(app. 1,815 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

    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 

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    Course leader & lecturers

    • Anne Vinding Sillemann
      Course leader
      Regulatory Principal Specialist, GRL, RA Rare Endocrine Disorders
      Novo Nordisk A/S
    • Mette Stie Kallesøe
      Lecturer
      Head of Pharmacovigilance QPPV
      Hansa Biopharma AB
    • Mette Maegaard Sonne
      Lecturer
      Director
      Ferring Pharmaceuticals A/S
    • Helen Shennan
      Lecturer
      Regulatory Affairs Director
      AstraZeneca A/S
    • 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
    • Mie Gøde Andersen
      Lecturer
      Regulatory Affairs Specialist
      Novo Nordisk A/S
    • Anette Hjelmsmark
      Lecturer
      Senior Regulatory Intelligence Manager
      Novo Nordisk A/S
    • Margrethe Erbou Andersen
      Lecturer
      VP Regulatory Affairs
      -
    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

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

    Lecturers

    Mette Stie Kallesøe
    Head of Pharmacovigilance QPPV
    Hansa Biopharma AB
    Mette Maegaard Sonne
    Director
    Ferring Pharmaceuticals A/S
    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
    Mie Gøde Andersen
    Regulatory Affairs Specialist
    Novo Nordisk A/S
    Anette Hjelmsmark
    Senior Regulatory Intelligence Manager
    Novo Nordisk A/S
    Margrethe Erbou Andersen
    VP Regulatory Affairs
    -

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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