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
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Course leader(s) & Lecturer(s)
- Helen ShennanCourse leaderReguatory Affairs Head Nordic
AstraZeneca A/S - Hanne BrokoppLecturerNDA Principal Consultant
NDA Group, Luxembourg - Eva BøgeLecturerRegulatory Project Manager
Zealand Pharma A/S - Mie Gøde AndersenLecturerRegulatory Affairs Specialist
Novo Nordisk A/S - Mette Due Theilade ThomsenLecturerManaging Director
PIP Adviser - Mette Stie KallesøeLecturerSenior Principal Professional, Deputy QPPV
LEO Pharma A/S - Mette Maegaard SonneLecturerDirector
Ferring Pharmaceuticals A/S - Anette HjelmsmarkLecturerSenior Regulatory Intelligence Manager
Novo Nordisk A/S - Christina Balslev RindshøjLecturerSenior Director
Ozack ApS - Robert Navy ErichsenLecturerSenior Project Manager
Novo Nordisk A/S
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
- 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 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)
NDA Group, Luxembourg
Zealand Pharma A/S
AstraZeneca A/S
Novo Nordisk A/S
PIP Adviser
LEO Pharma A/S
Ferring Pharmaceuticals A/S
Novo Nordisk A/S
Ozack ApS
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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