Summary
As a regulatory strategist, you play an important role in the entire drug development process.
Regulatory strategy is crucial for any company that wishes to develop new and effective drugs in compliance with regulator’s expectations, while facilitating a faster and more efficient drug development process.
On this three-day course, you will examine regulatory affairs decisions and strategies closely and gain an in-depth understanding of how and why they are made.
Regulatory affairs courses typically focus on laws, guidelines, and directives, but offer little insight into the role of regulatory strategy experts within project teams.
This course takes a different approach: rather than informing about legislation and guidelines, it explores the background of global regulatory strategies and the considerations that shape them.
It also examines how the regulatory strategist works with the various stakeholders involved in developing a solid global regulatory strategy plan.
If you are an experienced regulatory affairs professional, you will benefit greatly from the insights shared by several internationally experienced lecturers in this course.
Other course participants say
"The information shared was very relevant, up to date and set in a real-world perspective. Useful course with a great team supporting a nice learning environment."
Patrick Beke, RA Manager, Infant Bacterial Therapeutics AB
"The structure and contents were really well thought out and our course leaders and presenters were engaging and friendly."
Naja Støckel Jessen, Global Regulatory Affairs Professional, CMC, AJ Vaccines 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
- Margrethe Erbou AndersenCourse leaderNordic Head of Regulatory Affairs
PharmaRelations ApS - Gunvor Lind TolborgCourse leaderSenior Manager
Pharma IT Aps - Daniel BrathLecturerMarket Access, Pricing and Public Affairs
- - Sofie de Fine LichtLecturerMedical Evidence Team Lead
AstraZeneca A/S - Alma SahlLecturerRegulatory Specialist, Global Regulatory Lead
Novo Nordisk A/S - Anne Louise KirkegaardLecturer
ALK-Abelló A/S - Allan Dahl RasmussenLecturerDirector, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S - Annette MattssonLecturerVice President Regulatory Affairs
Camurus AB - Britta RosenqvistLecturerGlobal Regulatory Strategy Leader, Senior Specialist
H. Lundbeck A/S - Simon Suhr BorkenfeltLecturerSenior Patent Specialist
H. Lundbeck A/S - Mads Gjelstrup KristensenLecturerPrincipal Regulatory Specialist
LEO Pharma 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, who recently started working with regulatory strategies, or aspire to become a regulatory lead or strategist soon. To benefit from this course, you must have a solid knowledge of the legislative framework and guidelines applicable for the EU and the US.
What you will learn
- How to develop a global regulatory strategy for products in various stages of the product life cycle
- How to analyse strengths and weaknesses of a product when developing a regulatory strategy and a target label
- What the various stakeholders involved in the development of a regulatory strategy are
- The roles and deliverables of a regulatory strategist operating in a dynamic environment, to ensure the regulatory strategy meets the needs of internal and external business partners and health authorities
What your company will get
- A regulatory affairs professional who can play an active and effective role in the entire drug development process
- A regulatory affairs professional who can develop a global regulatory strategy for products in various stages of the product life cycle
- A regulatory affairs professional who can manage the complex environment and many stakeholders involved in the development and execution of a regulatory strategy
- A regulatory affairs professional who understands the roles and responsibilities of a regulatory strategist
Course calendar
Day 1
- Introduction to regulatory strategy
- The target label: key elements, sources of information and studies
- Non-clinical studies and their role in the regulatory strategy
- CMC: strategic considerations and their impact on the regulatory strategy
- Group work and learning sessions
Day 2
- Clinical development and its impact on regulatory strategy
- Real- world evidence and real-world data: their role in the regulatory strategy
- Regulatory strategy from an EU and a US perspective
- Group work and learning sessions
Day 3
- Intellectual Property (IP): how patents and exclusivities affect the regulatory strategy
- Market Access: connection with the global regulatory strategy
- Life cycle management strategies
- Group work and learning sessions
Registration
Registration deadline13 May 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will receive information about mandatory and optional readings. You are expected to familiarise yourself with the mandatory readings before starting the course. These readings are also a part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level or higher and be experienced within regulatory affairs. It is a benefit to have completed the courses “EU Pharmaceutical Framework & Approvals” and “The US Regulatory Environment” before joining this course. Alternatively, have knowledge of Regulatory Affairs at a level similar to what is being taught on these courses.
If you do not fulfil the requirements, you can still apply if you have experience in the pharmaceutical or biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of positions are filled by applicants with no or limited experience in regulatory affairs. We consider all applications 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
PharmaRelations ApS
Pharma IT Aps
Lecturers
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AstraZeneca A/S
Novo Nordisk A/S
ALK-Abelló A/S
H. Lundbeck A/S
Camurus AB
H. Lundbeck A/S
H. Lundbeck A/S
LEO Pharma A/S
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22 Jun 2026
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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