Summary
This comprehensive two-day course is designed to elevate your medical writing skills and drive success in regulatory writing within both clinical and pharmacovigilance communication (e.g. investigator brochures (IBs), protocols, clinical study reports, clinical overview, development safety update reports (DSURs), periodic safety update reports (PSURs) and risk management plans (RMPs)).
The program has been carefully planned to cover a broad range of topics within the medical writing field and industry experts will guide you through the various agenda items.
The course starts with an overall introduction to the content of the documents and how they are interlinked. It will also include the regulatory review processes and what assessors focus on when reviewing the documents. Later we will discuss general competencies that are relevant for medical writers. Selected areas within this field encompass lean writing, getting your key messages to stand out clearly and directing your writing to right target audience. Additionally, you will learn how to best handle stakeholder interactions and manage your projects, so you ensure an efficient writing and review process. Lastly, we will also touch upon key features of the future of medical writing, namely the role of artificial intelligence (AI) and structured content.
This dynamic and interactive course will feature engaging class discussions, medical writing examples, and group exercises, allowing you to put theoretical concepts into real-world practice, empowering you to enhance your regulatory communication skills.
Other course participants say
"I feel really inspired after this course. It was a great programme, with enough breaks so that you could take it all in. I personally learned a lot and have already communicated some of the learnings to my colleagues."
Sarah Kimmer Werther, Regulatory Professional
Keywords
- Clinical medical writing
- Pharmacovigilance medical writing
- Industry guidance and resources
- The regulatory reviewer
- Effective communication
- Artificial intelligence in medical writing
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Course leader & lecturers
- Bente RiisCourse leaderSenior Director, Medical Writing
Pharmacosmos A/S - Anne Førrisdahl SteenCourse leaderCompetency Development Specialist
Novo Nordisk A/S - Tanja JensenLecturerSpecialist Medical Writer
H. Lundbeck A/S - Sophie McMonagleLecturerInformation Architect
Novo Nordisk A/S - Susanne Thestrup OkkelsLecturerAdvanced Digital Innovation Professional
Novo Nordisk A/S - Kathleen StolpeLecturerAssociate Director
Novo Nordisk A/S - Martin BennetzenLecturerCEO
zitilite - Gregory CuppanLecturerManaging Principal
McCulley/Cuppan Inc. - Matilde Thye KveiborgLecturerSenior Director, Medical Documentation
H. Lundbeck A/S - Nynne Bayram NymannLecturerSenior SafeSurv Content Manager
Novo Nordisk A/S - Ebru Karakoc MadsenLecturerAssociate Regulatory Policy Director, Neurologist, MD
Novo Nordisk A/S
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Is this course for you?
This course is for you if you are a regulatory, clinical or safety medical writers.
Safety surveillance advisors writing safety documents.
Others in the pharmaceutical industry with a good understanding of clinical development but wanting to know more about the specifics of medical writing.
What you will learn
- Gain comprehensive understanding of regulatory documents in clinical development, regulatory review processes, and the importance of efficient writing techniques.
- Practical skills for implementing findings across different documents.
- Explore the role of AI and structured content in medical writing and understand how to enhance their work processes and written communication skills.
What your company will get
- An employee who knows how to better meet regulatory requirements in an efficient way
- An employee who understands how the different regulatory documents are interlinked
- An employee with an enhanced understanding of the regulatory reviewers
- An employee who can contribute to improved communication and more efficient review processes
- A professional who is familiar with how AI and structured authoring can be used in medical writing
Course information
Examination
There is no examination for this course.
Course leaders
Pharmacosmos A/S
Novo Nordisk A/S
Lecturers
H. Lundbeck A/S
Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk A/S
zitilite
McCulley/Cuppan Inc.
H. Lundbeck A/S
Novo Nordisk A/S
Novo Nordisk A/S
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18 Nov 2026
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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