The new Annex 22 on Artificial Intelligence - Online Training Recording
Evaluation of the Draft and its Impact on GMP Applications
Course No. 22616
Speakers
Dr Arno Terhechte
GMP inspectorate / Bezirksregierung Münster
Stefan Münch
Körber Pharma Consulting
Target Group
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.
Objectives
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.
Programme
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
Further Information
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.
Testimonials
