AI Excellence: GenAI in Drug Safety

Apply GenAI safely and effectively in your everyday drug safety tasks

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10 May and 25 May 2027

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Online and on location

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English

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9,200 DKK ex VAT
50% discount for public institutions i
You cannot combine different discounts and offers. See our terms and conditions for more information.

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 Melchiorsen
    Course 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

  1. How GenAI and agentic AI work, and which tools to use when
  2. Prompt engineering with persona, audience, task context and tactics, and your own prompt library
  3. Hands-on use cases: case summaries from AE narratives, follow-up questions, causality assessment, signal background and QC of documents
  4. Working with agents: building a simple reusable assistant with human review built in
  5. Compliant use: FDA/EMA principles, EU AI Act, and which tools may handle which data
  6. GxP assurance basics: documenting AI use, human review records, and when AI output enters a controlled record
  7. Verifying outputs: spotting hallucinations and bias, and checking against sources

What your company will get

An employee who:

  1. Can translate strategy into AI-supported ways of working across their whole team
  2. Works faster and with better quality across all tasks incl. case documentation, follow-up and safety reporting
  3. Is trained in the ethical and regulatory use of GenAI, including acceptable platforms and data handling
  4. Brings back reusable materials, prompt libraries and exercises to share adopting with colleagues

Course calendar

Starting 10 May 2027
10 May 2027 9:00-16:00
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
25 May 2027 9:00-11:00
Day 2 (09:00-11:00, online)
  • Present back: your use cases and how you have driven adoption in your team
Practical information

Registration

Registration deadline
6 May 2027
Atrium
Lersø Parkallé 101
2100 København Ø
Price
9,200 DKK
Register
10 - 25 May
Please note: The programme structure may be subject to minor adjustments

Course information

Literature

Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.

Prerequisites

N/A

Examination

There is no examination for this course.

Course leader

Ingelise Bærentzen Melchiorsen

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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