Yves Samson
Kereon
Referierende
Stefan Münch
Körber Pharma Consulting
Daniel Santak Wolf
Ulm University Hospital
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.
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
Zielgruppe
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.
Zielsetzung
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.
Programm
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
Weitere Informationen
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: 45 3396 50-00
Email guest.copenhagen@radissonblu.com
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: 45 3396 50-00
Email guest.copenhagen@radissonblu.com
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.
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.
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.
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.
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.
Contact
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de.
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de.
Questions regarding Organisation:
Mr Maximillian Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
Mr Maximillian Bauer, +49 6221 84 44-25, bauer@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 06 October 2026, 09:00-18:00 h
(Registration and coffee 08:30-09:00 h)
(Registration and coffee 08:30-09:00 h)
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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