Stefan Münch
Körber Pharma Consulting
Referent:innen
Yves Samson
Kereon
Ib Alstrup
Danish Medicines Agency (DKMA)
Veit Mengling
d-fine
Dr Jörg Stüben
Boehringer Ingelheim International
Torsten Kneuss
Bayer
Daniel Wolf
Universitätsklinikum Ulm
Dr Philipp Fey
Boehringer Ingelheim
Dr Rolf Roth
Merck Healthcare
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory
Dr Gitte Bjørg Windfeldt
Novo Nordisk
Kevin Françoisse
Ellion x Sagacify
Victor Bechmann
Kuatro group
Note: All times mentioned are CET. All times mentioned are CET. Combination booking: Save € 400,- by booking both conferences! You can also book an individual conference separately. Book "Pre-Conference Course on Basics of AI" here. Book "Annex 22 / AI Conference 2025" here.
Zielsetzung
Pre-Conference Course on Basics of AI
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
Hintergrund
Pre-Conference Course on Basics of AI
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.
Annex 22 / AI Conference 2025
Since ChatGPT, Bard, Midjourney and others, artificial intelligence (AI) has reached the general public. Opinions fluctuate between absolute euphoria and the evocation of the downfall of humanity. The foundations of AI were laid many years ago and can now be realised on a large scale thanks to the massive computing power available.
The topic has also found its way into the pharmaceutical and medical technology industry. The drafts published by the EU Commission on 7 July 2025 for the new version of EU GMP Annex 11 on computerised systems and the new Annex 22 on AI will also be dedicated to this topic.
The first applications have now been established in pharmaceutical companies. The interesting question is whether and how this technology is compatible with pharmaceutical regulations, specifications and the expectations of the authorities. Several case studies will look at various possible applications.
The topic has also found its way into the pharmaceutical and medical technology industry. The drafts published by the EU Commission on 7 July 2025 for the new version of EU GMP Annex 11 on computerised systems and the new Annex 22 on AI will also be dedicated to this topic.
The first applications have now been established in pharmaceutical companies. The interesting question is whether and how this technology is compatible with pharmaceutical regulations, specifications and the expectations of the authorities. Several case studies will look at various possible applications.
Zielgruppe
Pre-Conference Course on Basics of AI
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.
Annex 22/ AI Conference 2025
The conference is aimed at managers and interested parties from the pharmaceutical industry, suppliers and service companies who decide on the use of AI and (want to) qualify and operate AI applications in a GxP environment.
Date / Venue / Presentations / Certificate
Pre-Conference Course on Basics of AI
Tuesday, 4 November 2025, 09.00 – 17.00 h
(Registration and coffee 08.30 h - 09.00 h)
Annex 22 / AI Conference 2025
Wednesday, 5 November 2025, 09.00 h – 18.00 h
(Registration and coffee 08.30 h - 09.00 h)
Thursday, 6 November 2025 2025, 08.30 h – 16.30 h
After the event, you will automatically receive your certificate of participation.
Tuesday, 4 November 2025, 09.00 – 17.00 h
(Registration and coffee 08.30 h - 09.00 h)
Annex 22 / AI Conference 2025
Wednesday, 5 November 2025, 09.00 h – 18.00 h
(Registration and coffee 08.30 h - 09.00 h)
Thursday, 6 November 2025 2025, 08.30 h – 16.30 h
Venue
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Pre-Conference Course on Basics of AI - 04 November 2025
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
Annex 22 / AI Conference 2025 - 05-06 November 2025
Overview of AI in GxP: Capabilities & Opportunities
- General introduction
- (Very) brief introduction to AI & ML
- Drivers (for using AI & ML in pharma)
- Regulations and guidances
AI Limitations and Areas of Concern
- Current situation
- What do you need to watch out for?
- What are the risks?
Current regulatory Situation – the new EU GMP Guide Annex 11 and Annex 22 - and Expectations in the Context of an Inspection
Inspection Readiness
- Overview of supporting processes: data management, risk management, change management
- Have documentation ready – provide reasoning and justifications
- How to setup mock inspections successfully
Aspects of AI Adoption “with and beyond Regulations”
- Regulations and the degree of freedom
- What you may want to consider
- Examples and evaluation criteria
Interactive Presentations
AI in Imaging: An Interactive Introduction with Real-World Examples
- Understand each key step in building an AI model for imaging: data preparation, training, pre-training, testing, and explainability
- Learn through a real-world example: cancer diagnosis and prognosis based on CT scans
- Explore what’s next: opportunities and risks of using large pre-trained multimodal AI models
- Engage actively: think, ask, discuss - your participation shapes the session
- Leave with a clear understanding of how AI can support your own imaging challenges
Basics of Prompt Engineering
- Introduction to ChatGPT and current Large Language Models
- Overview of prompt engineering
- Prompt techniques
- Zero-shot prompting, few-shot prompting
- Chain-of Thought
- Tree of Thought (ToT)
- Reverse Engineering Prompting
- Example use cases
Case Studies
Artificial Intelligence (AI) for Discrepancy Management
Using AI in Pharmaceutical Manufacturing
- Approach for implementation
- Use of AI in Pharmaceutical Manufacturing
- Using AI for visual GMP Inspections
AI Coding Agents
- Overview: Evolution of AI coding agents
- State-of-the-Art: Current capabilities and limitations
- Use Cases: Beyond coding
- Outlook & Transfer: Future vision and imaging agent capabilities
AI Deviation Assistant – Enhancing Deviation Workflows
- Deviation management challenges in pharma
- AI-powered solution: Knowledge Graph / LLM RAG
- Key features, benefits, and impact
- Demo and use cases
Validating LLMs for GMP: A Framework for Document-Centric Use Cases
- Risk-based validation strategies for LLM-based systems
- Defining appropriate performance metrics for mixed-content data
- Human-in-the-loop controls to ensure accuracy and compliance
- Considerations for traceability, auditability, and change management
Learning from the Banking Sector: Transfer of AI-based Inspection Tools into GxP regulated Environment
- How we can learn from other industries: Conducting AI-based compliance audits in the banking & insurance sector (example: DORA regulation)
- Goal: The way to systematic and GDPR-compliant document checks without language barrier
- Solution: Fast-track AI-supported inspections of quality management systems in GMP systems
- Why auditors are still mandatory: Checking the implementation status of written standards
- AI never sleeps: Failure-free creation of risk-based compliance inspection reports
- Verification versus GMP validation: The limitations of AI tools in GxP practice
| ECA-Member*: | € 2680,- |
| Non ECA Member*: | € 3080,- |
| EU/GMP Inspectorates*: | € 1340,- |
| APIC Member Discount*: | € 2880,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
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Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
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E-Mail: info@concept-heidelberg.de
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