Training course – EU AI Act & AI Compliance – Pharma & Life Sciences

EU AI Act & AI Compliance for Pharma and Life Sciences

Putting the EU AI Act into practice: risk categories, deployer obligations, AI literacy under Art. 4, AI policy and GDPR interfaces.

Duration
6 hours, one session
Format
Online or on-site
Language
German or English
Participants
open dates or exclusive for your team
Certificate
Certificate of attendance

Overview

“EU AI Act & AI Compliance for Pharma and Life Sciences” is a hands-on course for roles such as Regulatory affairs professionals, Quality assurance and Qualified Persons and Clinical operations and medical writers. Rather than learning EU AI Act & AI Compliance in the abstract, you work on tasks from your daily routine – with examples, exercises and templates from Pharma & Life Sciences.

The EU AI Act is the first comprehensive legal framework for artificial intelligence, and it applies not only to providers but also to organisations that use AI systems in their daily work. In this compact course you will learn how the regulation is structured: prohibited practices, high-risk systems, transparency obligations and general-purpose AI models. You will find out which role your organisation plays as a deployer, which obligations follow and how to record and classify the AI applications you use in a structured way.

The practical part turns the requirements into manageable steps. You clarify what the AI literacy obligation under Article 4 means in concrete terms, how to organise training in a verifiable way and what an internal AI policy should cover. You also examine the interfaces with the GDPR, such as legal bases, data protection impact assessments and automated decision-making. You leave with an AI inventory template, a draft policy and a clear compliance roadmap for your area of work.

Pharmaceutical, biotech and medtech companies operate in one of the most heavily regulated environments of all. Documentation, validation and traceability shape daily work from research and clinical trials to manufacturing. Generative AI offers significant potential: AI assistants review scientific literature, help draft study protocols, regulatory documents and SOPs, summarise deviation reports, support pharmacovigilance case processing and prepare medical information for healthcare professionals. Automation supports change control, CAPA tracking and regulatory intelligence. At the same time, as soon as AI touches GxP-relevant processes, validation, data integrity according to ALCOA+ and clear accountability are mandatory. Adoption succeeds when companies clearly separate non-regulated support from GxP use and involve quality assurance early.

The course is delivered live – either online in a virtual classroom or on-site in our training rooms in Munich, Salzburg, Berlin, Augsburg, Hanover, Bremen, Stuttgart and Kaiserslautern. We can also run it exclusively for your team.

Who is this course for?

  • Regulatory affairs professionals
  • Quality assurance and Qualified Persons
  • Clinical operations and medical writers
  • Pharmacovigilance and drug safety teams
  • Medical affairs and R&D scientists

Typical challenges we address

  • Producing extensive regulatory and scientific documents to a high standard
  • Processing deviations, CAPAs and change controls on time
  • Systematically evaluating growing volumes of literature and regulation
  • Using AI tools in a GxP-compliant, validatable way

What you will be able to do

  • You can explain how the EU AI Act is structured and assign your organisation to the correct roles.
  • You can classify the AI applications in use by risk category and maintain an AI inventory.
  • You can name the specific obligations of deployers and derive appropriate measures.
  • You can develop an AI literacy concept under Article 4 and a draft internal AI policy.
  • Use AI for literature review, medical writing and regulatory intelligence.
  • Distinguish non-regulated AI use from GxP-relevant applications and understand validation requirements.
  • Safeguard data integrity, confidentiality and patient data protection when using AI.

Course outline

Module 1 Structure and logic of the EU AI Act
  • Objectives, scope and phased application of the regulation
  • Roles at a glance: provider, deployer, importer and distributor
  • The risk-based approach: prohibited practices, high risk, limited risk and minimal risk
  • Specific rules for general-purpose AI models
Module 2 Classifying risk in practice
  • Prohibited practices such as social scoring or emotion recognition in the workplace
  • High-risk areas under Annex III, including recruitment, creditworthiness and education
  • Transparency obligations for chatbots, synthetic content and deepfakes
  • Recording and classifying your own AI applications in an AI inventory
Module 3 Obligations for deployers of AI systems
  • Use in line with instructions and human oversight by competent staff
  • Input data quality, monitoring of operation and retention of logs
  • Informing employees and affected persons and reporting serious incidents
  • Fundamental rights impact assessment: when it is required and how it works
Module 4 AI literacy under Art. 4 and internal AI policy
  • What sufficient AI literacy means for different roles
  • Designing training concepts and documenting measures verifiably
  • Components of an AI policy: approved tools, data classes, approvals and labelling
  • Responsibilities, AI officers and involving the works council and IT
Module 5 GDPR interfaces and governance
  • Legal bases, purpose limitation and data minimisation when using AI
  • Data protection impact assessment and its relationship to the fundamental rights assessment
  • Automated individual decisions, data subject rights and data processing agreements
  • Compliance roadmap: priorities, ownership and regular review
Module 6 Practice lab: Pharma & Life Sciences
  • Literature review and evidence
  • Medical writing support
  • SOPs and training materials
  • Deviations and CAPA
  • Regulatory intelligence
  • Pharmacovigilance support
Module 7 Data protection, quality & transfer to daily work
  • When AI systems are used in GxP-relevant processes, computerised system validation under EU GMP Annex 11 or 21 CFR Part 11 and data integrity according to ALCOA+ must be ensured. Clinical trial and pharmacovigilance data contain health data under Article 9 GDPR and may only be processed in pseudonymised form in approved environments.
  • Ground rules for safe AI use in your team
  • Checking results: facts, sources, tests and the four-eyes principle
  • Personal action plan for the next 30 days
  • Open questions, outlook and resources for further learning

Practical scenarios from your field

Literature review and evidence

An AI assistant summarises scientific publications, extracts study design, endpoints and results into tables and supports systematic reviews, with experts checking every data point against the original source.

Medical writing support

AI creates outlines and first drafts of study protocols, clinical study reports, investigator brochures or modules of the regulatory dossier based on approved templates and source data.

SOPs and training materials

Process descriptions and regulations are turned into draft SOPs, training slides and comprehension questions, which are then reviewed and approved through the validated document management system.

Deviations and CAPA

AI summarises deviation reports, structures root cause analyses, finds similar past cases and suggests CAPAs, which quality assurance evaluates and decides on.

Regulatory intelligence

Automations collect new guidelines and publications from the EMA, national authorities or the FDA; AI summarises changes and maps them to affected products and processes for an impact assessment.

Pharmacovigilance support

AI helps pre-structure case reports from unstructured text, extract relevant information on product, event and patient and detect duplicates, while medical assessment remains with qualified staff.

Prerequisites

No legal background is required. A basic knowledge of the GDPR and an overview of the AI applications used or planned in your area are helpful. You work in the pharmaceutical, biotech or medtech industry and know the GxP basics of your area.

Technical requirements

All you need is a laptop with an up-to-date browser and an office suite for working with templates. No special AI licences are necessary.

Data protection & compliance

When AI systems are used in GxP-relevant processes, computerised system validation under EU GMP Annex 11 or 21 CFR Part 11 and data integrity according to ALCOA+ must be ensured. Clinical trial and pharmacovigilance data contain health data under Article 9 GDPR and may only be processed in pseudonymised form in approved environments.

Dates & locations

For every location we suggest a date roughly four weeks ahead. Your preferred date is always possible.

  • Munich Tue, 15 December 2026 6 hrs Request
  • Salzburg Fri, 11 December 2026 6 hrs Request
  • Berlin Mon, 14 December 2026 6 hrs Request
  • Augsburg Fri, 11 December 2026 6 hrs Request
  • Hanover Thu, 10 December 2026 6 hrs Request
  • Bremen Tue, 15 December 2026 6 hrs Request
  • Stuttgart Mon, 14 December 2026 6 hrs Request
  • Kaiserslautern Thu, 10 December 2026 6 hrs Request
  • Online Tue, 15 December 2026 6 hrs Request

Frequently asked questions

Does the EU AI Act apply to companies that only use AI tools?

Yes. Anyone using AI systems under their own authority in a professional context is a deployer. All deployers must, in particular, ensure that their staff have sufficient AI literacy. Where high-risk systems are used, for example in recruitment, further obligations apply, such as human oversight, logging and informing the people affected.

Does this course satisfy the training obligation under Article 4?

The course covers core AI literacy content and you receive a certificate of attendance that you can add to your documentation. However, Article 4 requires measures tailored to role, prior knowledge and context of use. That is why you also learn how to set up and maintain your own AI literacy concept for your organisation.

Does the course replace legal advice?

No. The training provides practical knowledge for specialists and managers so they can interpret requirements, ask precise questions and implement first measures. For binding assessments of individual systems, especially in high-risk areas, you should involve your legal department, your data protection officer or external specialist lawyers.

Do AI tools need to be validated in pharma?

It depends on the use. For activities without GxP relevance, such as internal communication or literature overviews, general IT and data protection rules apply. If results feed into GxP-relevant decisions or records, a risk-based validation approach is required. We show you how to classify use cases.

How do we ensure data integrity?

AI output must be attributable, traceable and verifiable. That means documented inputs and prompts, clearly assigned reviewers, versioning and release through your validated systems. In the course we discuss how ALCOA+ principles apply to AI-supported work steps. Clear retention rules complete the picture.

How much does “EU AI Act & AI Compliance for Pharma and Life Sciences” cost?

The course costs a flat €949 plus VAT per participant – whether online or on-site. This includes 6 hours of live training with a trainer, course materials, a lab environment and a certificate of attendance.

Can I suggest my own date?

Yes. For every location we suggest a date roughly four weeks ahead. In the request form you can always describe your preferred date or period in free text – we check availability and get back to you within one working day.

Is the course online or on-site?

Both are possible: live online in a virtual classroom or on-site in Munich, Salzburg, Berlin, Augsburg, Hanover, Bremen, Stuttgart and Kaiserslautern. We can also run the course exclusively for your team.

Can the course be tailored to our team?

Yes. Tailor-made courses cost approx. €4,500 more, depending on the topic and by arrangement. We agree content, examples and exercises with you in advance.

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