EU AI Act Course & Certification

Intermediate

Practical Compliance, Risk Management + Implementation

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4.7

★★★★★★

97% Recommended

Updated 2026
3 hours
125 active users
2 points

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1 x EU AI Act

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Each course includes:

Fully compliant

This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

Certified

All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.

Affordable

Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.

Time-saving

Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.

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About

The EU AI Act Course & Certification is designed to provide a clear understanding of the European Union’s regulatory framework governing the development, deployment, and use of Artificial Intelligence systems. The course focuses on ensuring safe, transparent, and trustworthy AI practices, particularly in high-risk sectors such as healthcare, pharmaceuticals, and clinical research.
This course covers key provisions of the EU AI Act, risk-based classification of AI systems, compliance obligations, data governance, transparency requirements, conformity assessments, and enforcement mechanisms. It also emphasizes ethical AI use, accountability, documentation standards, and alignment with other global regulations. Upon successful completion, learners receive a certification demonstrating competency in EU AI Act compliance.

Who Should Enrol ?:

AI/ML Professionals in Healthcare and Life Sciences
Regulatory Affairs and Compliance Professionals
Clinical Research and Pharmacovigilance Teams
Pharmaceutical and Biotechnology Professionals
Data Science and Analytics Teams
Quality Assurance and Validation Professionals
IT and Software Development Teams in Regulated Industries
Life Science, Pharmacy, Engineering, and Medical Graduates

What you will learn

Understand the fundamentals of the EU AI Act, including its objectives, scope, and regulatory framework for governing artificial intelligence systems.

Learn how AI systems are classified using a risk-based approach and the obligations placed on stakeholders across the AI value chain.

Gain knowledge of compliance requirements for high-risk AI systems, including conformity assessments, governance structures, and fundamental rights impact assessments.

Develop an understanding of enforcement mechanisms, penalties, regulatory interplay, and practical implementation strategies for EU AI Act compliance in real-world settings.

Course Syllabus

Introduction to the EU AI Act
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
Quick-scope test — does the Act apply to you?
Implementation steps
Top failure modes + penalties
Key points to carry forward

Risk-Based Classification of AI Systems
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
Classification flowchart — quick-pass triage
Implementation steps
Top failure modes + penalties
Key points to carry forward

Obligations Across the AI Value Chain
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
RACI — duties at a glance across the value chain
Implementation steps
Top failure modes + penalties
Key points to carry forward

High-Risk AI Systems — Deep Dive
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
High-risk compliance checklist — the 7-article gate
Implementation steps
Top failure modes + penalties
Key points to carry forward

Conformity Assessments + Compliance Processes
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
Audit-readiness dossier — what the notified body will ask for
Implementation steps
Top failure modes + penalties
Key points to carry forward

Fundamental Rights Impact Assessment (FRIA)
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
FRIA methodology — six-step template
Implementation steps
Top failure modes + penalties
Key points to carry forward

Enforcement, Penalties + Governance
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
Serious-incident reporting — 15-day playbook
Implementation steps
Top failure modes + penalties
Key points to carry forward

Interplay with Other Regulations
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
Regulation-overlay stack — one governance programme, many inputs
Implementation steps
Top failure modes + penalties
Key points to carry forward

Implementing the EU AI Act in Practice
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
The 90-day plan — what to do in the first quarter
Implementation steps
Top failure modes + penalties
Key points to carry forward

Future Outlook + Global Impact
Concepts (part 1)
Concepts (part 2)
Healthcare + enterprise perspectives
What would you do?
Global AI compliance — regime comparison
Implementation steps
Top failure modes + penalties
Key points to carry forward

How this assessment works
Scoring + the credential
What your Certificate of Completion delivers
Apply the course — the first 30 days
Completion slide

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Rinaldo Cavallo

Country Manager Italy, Scandinavia and Portugal

★5•2 weeks ago

Working with Whitehall training for the last two years of partnership has been a very successful experience – I have fast access to all the GCP course...

Clara Fargo

EBMT Clinical Research Quality Assurance Coordinator

★5•2 days ago

I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...

Frequently Asked Questions

Regulatory Affairs & Compliance Professionals dealing with AI systems
Legal & Policy Experts focused on EU digital and AI regulations
Quality Assurance & Risk Management Professionals
AI/ML Developers, Data Scientists, and Software Engineers
Healthcare, Pharmaceutical & Medical Device Professionals using AI
CROs, Sponsors, Importers, Distributors, and AI Solution Providers

This module provides a comprehensive understanding of the EU AI Act, focusing on risk classification, regulatory requirements, conformity assessment, and compliance obligations to ensure AI systems are safe, transparent, and aligned with European regulatory standards throughout their lifecycle.

Developed by EU regulatory and AI governance experts
Focused on practical implementation of EU AI Act requirements
Covers risk classification, conformity assessment, and compliance obligations
Relevant for professionals across AI, healthcare, pharma, and digital sectors
Supports regulatory readiness, audit preparedness, and responsible AI deployment