Dr Arno Terhechte
GMP inspectorate / Bezirksregierung Münster
Referent:innen
Stefan Münch
Körber Pharma Consulting
All times mentioned are in CEST
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.
Date / Technical Requirements / Presentations / Certificate
Date of the Live Online Training
Tuesday, 23 September 2025, 14:00h – 16:00h
All times mentioned are in CEST
Tuesday, 23 September 2025, 14:00h – 16:00h
All times mentioned are in CEST
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
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
Question and Answer Session and Discussion
Moderated by both speakers
At the end, there will be an opportunity to ask the speakers Questions and discuss specific aspects, such as:
- Which AI applications are specifically affected?
- What does the annex mean for existing systems?
- What measures should be prepared now?
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