Speakers

Stefan Münch

Stefan Münch

Körber Pharma Consulting

Yves Samson

Yves Samson

Kereon

Veit Mengling

Veit Mengling

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Note: All times mentioned are CET. If you book this conference together with the "Annex 22 / AI Conference 2025", we will offer you a discount of € 400,-. Book both conferences directly as a combination here.

Objectives

What can you expect in the Pre-Conference Course?
  • Get to know the basics of AI (Artificial Intelligence) and ML (Machine Learning),
  • Learn about the importance of data and models,
  • Risk management and validation; how should these classic pharmaceutical topics be considered and applied in the context of AI and
  • What are the applications and limitations in the GxP environment? Learn about the current state of development

Background

In addition to the general public, the topic of artificial intelligence now also has the healthcare industry in its grip. In order to assess and apply the technology in a meaningful way, it is important to understand the basics. What technologies is AI based on? What is the significance of data - data quality - data availability and models? The pre-training course offers you a first introduction to the topic.

Target Group

The pre-conference is aimed at managers and interested parties from the pharmaceutical industry, suppliers and service companies who want to find out about the basics of AI and its possible applications in the pharmaceutical environment.

Date / Venue / Presentations / Certificate

Date
Tuesday, 4 November 2025, 09.00 – 17.00 h
(Registration and coffee 08.30 h - 09.00 h)

Venue
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com

 

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.

After the event, you will automatically receive your certificate of participation.

Programme

Pre-Conference Course on Basics of AI

Seminar Programme as PDF

Introduction to Artificial Intelligence (AI)
  • History of AI
  • Types of AI
  • Current situation
  • Real life examples
Introduction to Machine Learning (ML)
  • Technological basics
  • Different learning / training methods
  • Example use cases
Data and Models
  • Classification of data and models
  • Regulators’ thinking in the context of data and models
  • Data quality considerations and challenges
  • Data handling practices: Splitting, selection and synthesization
  • Model version management and model updates
Generative AI
  • Introduction to Large Language Models (LLM)
  • Tailoring LLMs for your business case
  • Typical risks when using LLMs
  • Performance evaluation and validation strategies for LLMs
Risk Management for AI/ML
  • Basics of a ML Risk and Control Framework
  • Applying QRM to development and operation of AI applications
  • Using hazard clusters to guide the risk process
Validation Approaches
  • Maturity: Increasing autonomy and transferring control
  • Governance: Developing and operating AI solutions in GxP-regulated areas
  • Lifecycle approach and Good Machine Learning Practice (details)
AI / ML in Pharma, Biotech, and Medical Devices
  • Challenges for the Life Science industry
  • The GAMP® perspective on AI/ML
  • The EU AI Act and its impact on the Life Science industry

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This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more

ECA-Member*: € 1090,-
Regular Fee*: € 1290,-
EU/GMP Inspectorates*: € 645,-
APIC Member Discount*: € 1190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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