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
- Helen ShennanCourse leaderRegulatory Affairs Director
AstraZeneca A/S - Mette Stie KallesøeLecturerHead of Pharmacovigilance QPPV
Hansa Biopharma AB - Mette Maegaard SonneLecturerDirector
Ferring Pharmaceuticals A/S - Mette Due Theilade ThomsenLecturerManaging Director
PIP Adviser - Hanne BrokoppLecturerNDA Principal Consultant
NDA Group, Luxembourg - Eva BøgeLecturerRegulatory Project Manager
Zealand Pharma A/S - Christina Balslev RindshøjLecturerVP, Head of Regulatory Affairs
Zealand Pharma A/S - Anette HjelmsmarkLecturerSenior Regulatory Intelligence 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
- 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
Day 2
- Summary of day 1
- Regulatory – clinical aspects
- Pharmacovigilance
- eCTD – Organising Data
- Workshop
- Drug registration in the US
- Summing up and goodbye
Registration
Registration deadline23 Apr 2024
Lersø Parkallé 101
2100 København Ø
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
Day 2
- Summary of day 1
- Regulatory – clinical aspects
- Pharmacovigilance
- eCTD – Organising Data
- Workshop
- Drug registration in the US
- Summing up and goodbye
Registration
Registration deadline4 Sep 2024
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
AstraZeneca A/S
Lecturers
Hansa Biopharma AB
Ferring Pharmaceuticals A/S
PIP Adviser
AstraZeneca A/S
NDA Group, Luxembourg
Zealand Pharma A/S
Zealand Pharma A/S
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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