Summary
As a regulatory affairs expert, you play an active part in the entire drug development process. This is crucial if you wish to develop new and effective drugs, and at the same time meet the expectations of a faster and more efficient drug development process.
On this three day course, you will delve deep into regulatory decisions and strategies and get an in-depth understanding of how and why they are made. Regulatory courses normally focus on laws, guidelines, and directives, but offer little insight on the role of regulatory experts in project teams. Our course delves much deeper into the guidelines and explores the background of global regulatory strategies and the preceding considerations. If you are a regulatory affairs employee, then you will benefit greatly from this insight, which will be delivered by a number of internationally experienced lecturers.
Other course participants say
"Relevant programme for professionals working in clinical drug development, including RA professionals and other closely related functions. Great course leaders and lecturers. The perfect mix of lectures and group work."
Andrea Lampp, Senior Medical Writer, Novo Nordisk A/S
Keywords
- Regulatory Affairs Involvement in Product Development
- Regulatory Strategies
- Consultation with Authorities Throughout Development
- Regulatory Intelligence
- The Development of a Target Label
- Regulatory Planning
- Intellectual Property Rights
- Pricing and Reimbursement Negotiations
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Course leader & lecturers
- Helen ShennanCourse leaderRegulatory Affairs Director
AstraZeneca A/S - Margrethe Erbou AndersenCourse leaderHead of Regulatory Affairs Denmark
PharmaRelations ApS - Allan Dahl RasmussenLecturerDirector, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S - Alma SahlLecturerRegulatory Specialist, Global Regulatory Lead
Novo Nordisk A/S - Christina Balslev RindshøjLecturerVP, Head of Regulatory Affairs
Zealand Pharma A/S - Anne Louise KirkegaardLecturer
Pharma IT Aps - Annette MattssonLecturerVice President Regulatory Affairs
Camurus AB - Sophie Elisabeth HavezLecturerPrincipal Regulatory Professional
LEO Pharma A/S - Britta RosenqvistLecturerRegulatory Strategy Leader, Senior Specialist
H. Lundbeck A/S - Sofie de Fine LichtLecturerMedical Evidence Team Lead
AstraZeneca A/S - Daniel BrathLecturerSales Manager
- - Maria UldallLecturerPhD, Senior Patent Specialist | European Patent Attorney
H. Lundbeck A/S
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Is this course for you?
This course is for you if you are an experienced Regulatory Affairs professional, employed in the industry, a regulatory agency, or a consulting firm.
What you will learn
- How to develop a regulatory strategy for products in various stages of the product life cycle
- How to analyze strengths and weaknesses of a product in order to develop regulatory strategies and target product profiles
- How to use best practices when communicating a regulatory strategy to the company project team or top management
- To operate in a dynamic and changing environment, where internal as well as external business partners and authorities must understand the rationale of the product development
What your company will get
- A regulatory professional who can play an active, effective and crucial part in the entire development and decision-making process
- A regulatory professional who can develop a regulatory strategy for products in various stages of the product life cycle
- A regulatory affairs professional who can communicate a regulatory strategy to the company project team or top management
- A regulatory affairs professional who can operate in a highly dynamic and constantly changing environment
Course calendar
Day 1
- The role of regulatory affairs
- Introduction to regulatory strategy
- Target labelling – key elements, sources of information and the studies
- Regulatory strategy plan - the clinical studies supporting the target labelling
- Intellectual Property (IP) – activities in the pharma world
- Group work
Day 2
- Regulatory strategies and strategic considerations with focus on the USA
- Regulatory strategies and strategic considerations with focus on the EU
- Regulatory strategy plan – non-clinical
- Regulatory strategy plan – CMC development strategy
- Group Work
Day 3
- Development of a regulatory strategy – practical example
- Life cycle management strategies
- Communication and yourself
- Group work
Registration
Registration deadline7 May 2025
Lersø Parkallé 101
2100 København Ø
Day 1
- The role of regulatory affairs
- Introduction to regulatory strategy
- Target labelling – key elements, sources of information and the studies
- Regulatory strategy plan - the clinical studies supporting the target labelling
- Intellectual Property (IP) – activities in the pharma world
- Group work
Day 2
- Regulatory strategies and strategic considerations with focus on the USA
- Regulatory strategies and strategic considerations with focus on the EU
- Regulatory strategy plan – non-clinical
- Regulatory strategy plan – CMC development strategy
- Group Work
Day 3
- Development of a regulatory strategy – practical example
- Life cycle management strategies
- Communication and yourself
- Group work
Registration
Registration deadline22 Apr 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will receive information about mandatory and optional readings. Please familiarize yourself with the mandatory reading before starting the course. The mandatory reading is also a part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and experience in regulatory affairs or other equivalent qualifications. We consider all applications upon registration.
If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.
Examination
The exam is held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
This course is a part of a diploma
The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.
Read moreCourse leaders
AstraZeneca A/S
PharmaRelations ApS
Lecturers
H. Lundbeck A/S
Novo Nordisk A/S
Zealand Pharma A/S
Pharma IT Aps
Camurus AB
LEO Pharma A/S
H. Lundbeck A/S
AstraZeneca A/S
-
H. Lundbeck A/S
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