Summary
Drug safety work combines large volumes of text with strict quality and compliance demands. This hands-on course gives drug safety professionals the skills to use GenAI safely for case summaries, follow-up queries, causality assessment and signal documentation.
You practise prompt engineering and agents on public and fictional examples, learn where the risks and limits lie, and leave with a personal prompt library and develop 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:
Drug Safety Associate and Case Processors, Safety Scientist and Medical Reviewer, Drug Safety Physician, Signal Management and Aggregate Reporting Specialist, PV Manager, PV Quality and Compliance Specialist and PV Project Manager.
Also relevant for anyone exploring GenAI's future in drug safety.
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: case summaries from AE narratives, follow-up questions, causality assessment, signal background and QC of documents
- 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
An employee who:
- Can translate strategy into AI-supported ways of working across their whole team
- Works faster and with better quality across all tasks incl. case documentation, follow-up and safety reporting
- 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 drug safety 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 in your team
Registration
Registration deadline6 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
Examination
There is no examination for this course.
Course leader
IMPLEMENT Consulting Group
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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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