Combination booking: If you book this conference together with the "2nd Annex 22 / AI – Conference 2026 from 07/08 October 2026", we will offer you a discount of 400 EUR. Book here.
Highlights
- News about EU GMP Guide Annex 22 ‘Artificial Intelligence
- What Questions about AI can be expected during an inspection?
- Case Studies from CSL Behring / NNIT / Takeda
Target Group
The pre-conference is aimed at
Managers and interested parties from the pharmaceutical industry
Suppliers
Service companies
who want to find out more about the basics of AI and its possible applications in the pharmaceutical Environment.
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,
Understand the difference between specialised AI and generative AI,
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.
Programme
Introduction to Artificial Intelligence (AI) and Machine Learning (ML)
History of AI
Types of AI
Current situation and real-life examples
Technological Basics
Different learning / training Methods
Example use cases
Data and Models
Overview of core model architectures and data types
Data splitting: training, validation, and testing phases
Ensuring data quality, representativeness, and overcoming common bottlenecks
Specialised AI: How Task-Specific Models Work
Specialized vs. General-Purpose AI: Understanding the key differences
Step-by-step training process, using cancer diagnostics as a case study
The roles of pre-training and fine-tuning
Ensuring AI traceability and explainability in critical Tasks
General-Purpose AI: How Generative Models like GPT & Co. Work
Fundamentals of Large Language Models (LLMs)
Strengths and limitations of LLMs compared to specialized AI
Introduction to LLMs acting as autonomous agent
Risk Management / Validation for AI/ML Solutions
Applying ICH Q9 QRM to AI/ML
QRM throughout the System Life Cycle
Thinking critically about AI-enabled Computerized Systems
Using the AI Maturity Model
Achieving Data and Model Governance
Overview of AI/ML in Pharmaceuticals, Biotech and Medical Devices
Challenges facing the life sciences industry in dealing with AI and ML
GAMP® 5 meets AI: The GAMP AI Guide
Use cases for AI in pharma and biotechGMLP (Good Machine Learning Practice): An SDLC for AI/ML
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Conference language The official conference language will be English.
Fees (per delegate, plus VAT) ECA Members 1,090 EUR APIC Members 1,190 EUR Non-ECA Members 1,290 EUR EU GMP Inspectorates 645 EUR The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
We offer you a discount of 400 EUR if you book this training course together with the course "2nd Annex 22 / AI – Conference 2026" from 07/08 October 2026 here.
Presentations/Certificate 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.
Testimonials
