Combination booking: If you book this conference together with the "1 Day Pre-Conference Course on Basics of AI", we will offer you a discount of 400 EUR. 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
Target Group
The conference is aimed
At managers and interested parties from the pharmaceutical industry
Suppliers
Service companies
who decide on the use of AI and (want to) qualify and operate AI applications in a GxP Environment.
Objectives
You will gain an overview of the current state of regulatory development with regard to the use of AI in the pharmaceutical industry
You will be able to better assess the possibilities and limitations of this technology
You will learn more about the requirements for successfully implementing AI projects within the company
Case studies from pharmaceutical companies will show you possible areas of application for AI
AI has 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 final versions of both documents are expected to be published in late 2026 - early 2027 respectively.
However, even without the final version of Annex 22, the first applications of AI have already become 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.
Programme
Overview of AI in GxP: Capabilities & Opportunities
General introduction
Brief introduction to AI & ML
Drivers for using AI & ML in pharma
Regulations and guidance
AI Limitations and Areas of Concern
Current situation
What do you need to watch out for?
What are the risks?
Current regulatory Situation – The Current Status in Regard to EU GMP Guide Annex 11 and Annex 22 - and Expectations in the Context of an Inspection
Risks and Limitations of Large Language Models (LLMs): A Critical Discussion
Open-Source vs. Closed-Source: Transparency, control, and dependencies
Bias in training data and its impact on results
Data privacy and confidentiality when using generative AI
Hallucinations: Why LLMs generate convincingly false information
Security Implications of AI for Pharma Manufacturing
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.
Conference language The official conference language will be English.
Social Event
On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT) ECA Members 1,990 EUR APIC Members 1,190 EUR Non-ECA Members 2,190 EUR EU GMP Inspectorates 1,095 EUR The conference fee is payable in advance after receipt of invoice and includes conference documentation, social event including dinner on the first day, two lunches and all refreshments. VAT is reclaimable.
We offer you a discount of 400 EUR if you book this training course together with the course "1 Day Pre-Conference Course on Basics of AI" from 06 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.
Testimonials
