Dr Arno Terhechte
GMP inspectorate / Bezirksregierung Münster
Referent:innen
Stefan Münch
Körber Pharma Consulting
Zielsetzung
On 7 July 2025, three important draft documents relating to the EU GMP guidelines were published: the revised version of Annex 11 ‘Computerised Systems’, the new version of Chapter 4 “Documentation” and, for the first time, a separate Annex 22 ‘Artificial Intelligence’. The publication of Annex 22 is a milestone – for the first time, a regulatory document is specifically dedicated to the use of artificial intelligence in GxP-regulated Areas. The aim of this event is to analyse and critically evaluate the requirements of the new draft Annex 22 and to place it in the overall context of the applicable GMP regulations. The impact on existing systems and new requirements for the implementation and validation of AI systems will be examined. A particular focus will be placed on the practical consequences for pharmaceutical companies.
Zielgruppe
This seminar is aimed at specialists and managers from the pharmaceutical industry as well as their service providers and suppliers. It is particularly aimed at those responsible for quality assurance, production, IT, CSV, digitalisation, regulatory Affairs and project management in relation to AI Systems.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programm
Introduction and Background to Annex 22
Dr Arno Terhechte
- Regulatory context: Why a separate annex on artificial intelligence?
- Development history and objectives of Annex 22
- Overview of the structure and content of the draft
- Distinction from Annex 11 and Chapter 4 ‘Documentation’
- Assessment from the perspective of the supervisory authorities
Does Annex 22 close the Regulatory Gap? - The two Sides of the Coin - A Detailed Examination
Dr Arno Terhechte & Stefan Münch
Joint Discussion of Annex 22 – Paragraph by Paragraph
In an interactive format, the two speakers will examine the Contents of Annex 22 step by step – alternating between the perspective of the authorities and that of industry. The aim is to promote a common understanding of the requirements while identifying the practical challenges of implementation.
Topics covered include:
- Definition and delimitation of ‘artificial intelligence’ in the GxP context
- Requirements for training data and model transparency
- Validation and life cycle of AI systems
- Dealing with self-learning systems
- Requirements for documentation, traceability and audit trail
- Responsibilities and governance for AI applications
- Risk assessment and change control for AI-based processes
Recording from 23 September 2025
Duration of Recording: approx. 1h 41min
Duration of Recording: approx. 1h 41min
| ECA-Member*: | € 490,- |
| Regular Fee*: | € 590,- |
| EU/GMP Inspectorates*: | € 490,- |
| APIC Member Discount*: | € 540,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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