Summary
Generative AI is already changing how regulatory work gets done. This hands-on course gives Regulatory Affairs professionals the skills and confidence to use GenAI safely in a regulated environment. You practise prompt engineering and agents on real tasks such as variations, label and packaging checks, SmPC/SPL drafting and regulatory intelligence, learn where the risks and limits lie, and leave with a personal prompt library and a plan for your further development.
Key words
Generative AI
Prompt engineering
Agentic work
Regulatory compliance
Life Sciences
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Course leader & lecturers
- Ingelise Bærentzen MelchiorsenCourse leader
IMPLEMENT Consulting Group
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Is this course for you?
This course is for you if you work as a:
Regulatory Affairs Director or Manager, Regulatory Affairs Specialist and Associate, Regulatory Submission and Publishing Specialist, Labelling and Documentation Specialist, Regulatory Operations and RIM Specialist, Regulatory Intelligence Specialist, Strategy Leads and Regulatory Project Manager.
Also relevant for anyone exploring GenAI's future in Regulatory Affairs.
What you will learn
- How GenAI and agentic AI work, and which tools to use when
- Prompt engineering with persona, audience, task context and tactics, and your own prompt library
- Hands-on use cases: excipient checks against approved terms, variations for EMA and FDA, label and packaging checks, SmPC/SPL drafting and regulatory intelligence
- Working with agents: building a simple reusable assistant with human review built in
- Compliant use: FDA/EMA principles, EU AI Act, and which tools may handle which data
- GxP assurance basics: documenting AI use, human review records, and when AI output enters a controlled record
- Verifying outputs: spotting hallucinations and bias, and checking against sources
What your company will get
- Can translate strategy into AI-supported ways of working across their whole team
- Works faster and with better quality across all tasks incl. submissions, documentation & health-authority interactions
- Is trained in the ethical and regulatory use of GenAI, including acceptable platforms and data handling
- Brings back reusable materials, prompt libraries and exercises to share adopting with colleagues
Course calendar
Day 1 (09:00-16:00, online and face-to-face)
- Introduction and purpose: why AI now, expectations
- GenAI foundations: how it works, risks, bias and GxP basics
- Function-specific application: prompt engineering, agents, real regulatory use cases, hands-on tool work
- Reflection and adoption: applying it to your own work
Day 2 (09:00-11:00, online)
- • Present back: your use cases and how you have driven adoption of GenAI
Registration
Registration deadline9 May 2027
Lersø Parkallé 101
2100 København Ø
9,200 DKK
Course information
Literature
Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.
Prerequisites
Bring your computer
Examination
There is no examination for this course.
Course leader
IMPLEMENT Consulting Group
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13 May 2027
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Want to know more or need help?
Contact Client Manager Louise V. Petersen at +45 40 44 99 43
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