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
ANNIVERSARY OFFER:
Book any course* scheduled for a date in 2022 and bring a colleague along: 2 for the price of 1. Only valid for bookings made 2 May until 16 May.
Sign up yourself and a colleague in the same order form – then we make sure only one course fee is charged.
(*Networks and courses offered together with University of Copenhagen and CBS are not included.)

Course leader(s) & Lecturer(s)
- Helen ShennanCourse leaderReguatory Affairs Head Nordic
AstraZeneca A/S - Anette HjelmsmarkLecturerSenior Regulatory Intelligence Manager
Novo Nordisk A/S - Dorte Bjørn-LarsenLecturerSenior Regulatory Affairs Manager
Novo Nordisk A/S - Eva BøgeLecturerRegulatory Project Manager
Zealand Pharma A/S - Hanne BrokoppLecturerNDA Principal Consultant
Atrium - Mette Due Theilade ThomsenLecturerManaging Director
PIP Adviser - Mette Maegaard SonneLecturerDirector
Ferring Pharmaceuticals A/S - Mette Stie KallesøeLecturerSenior Principal Professional, Deputy QPPV
LEO Pharma A/S - Mie Gøde AndersenLecturerRegulatory Affairs Specialist
Novo Nordisk A/S - Christina RindshøjLecturerSenior Director
Ozack ApS
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
- The EU regulatory legislation
- How to obtain and maintain a marketing authorization in Europe
- The documentation required in support an application in Europe
- The many tasks of the regulatory affairs department
What your company will get
- An employee who understands the many tasks of the regulatory affairs department
- 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
- An employee who can act as a sparring partner to colleagues in regulatory affairs
- An employee who can provide better and more qualified support to colleagues in regulatory affairs
Course calendar
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
DAY 2
- Product information
- Quality - Seen from a Regulatory Affairs perspective
- Regulatory - Clinical aspects
- Pharmacovigilance
- eCTD
- Drug registration in the US
- Workshop
Registration
Registration deadline6 Oct 2022
Lersø Parkallé 101
2100 København Ø
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
DAY 2
- Product information
- Quality - Seen from a Regulatory Affairs perspective
- Regulatory - Clinical aspects
- Pharmacovigilance
- eCTD
- Drug registration in the US
- Workshop
Registration
Registration deadline23 Mar 2023
Lersø Parkallé 101
2100 København Ø
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
DAY 2
- Product information
- Quality - Seen from a Regulatory Affairs perspective
- Regulatory - Clinical aspects
- Pharmacovigilance
- eCTD
- Drug registration in the US
- Workshop
Registration
Registration deadline24 Aug 2023
Lersø Parkallé 101
2100 København Ø
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)
AstraZeneca A/S
Lecturer(s)
Novo Nordisk A/S
Novo Nordisk A/S
Zealand Pharma A/S
Atrium
AstraZeneca A/S
PIP Adviser
Ferring Pharmaceuticals A/S
LEO Pharma A/S
Novo Nordisk A/S
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
Send me a message