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 - Helle Frobøse SørensenCourse leaderPrincipal Medical Writer
ALK A/S - Kathleen StolpeLecturerAssociate Director
Novo Nordisk A/S - Martin BennetzenLecturerCEO
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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 calendar
Day 1
Regulatory Documents in Clinical Development & Post-Marketing
Knowing Your Audience: How to tailor your regulatory documents for a successful outcome
Regulatory Documents from an Assessor’s Point of View
- Lean and Efficient Writing – via MS Teams
General Q&A and wrapping up Day 1
Day 2
Structured Content
Agile Practical Project Management: Engaging stakeholders and managing time
AI in Medical Writing, incl. hands-on
Course Summary, Evaluation and Feedback
Registration
Registration deadline8 Apr 2027
Lersø Parkallé 101
2100 København Ø
Course information
Examination
There is no examination for this course.
Course leaders
Pharmacosmos A/S
ALK A/S
Lecturers
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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