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About

The EU AI Act is the European Union’s comprehensive regulatory framework designed to govern the development, deployment, and use of Artificial Intelligence (AI) systems across member states. It establishes a risk-based classification approach, categorizing AI systems into unacceptable risk, high risk, limited risk, and minimal risk, with corresponding obligations for transparency, safety, and accountability. As AI becomes increasingly embedded in healthcare, pharmaceuticals, finance, and other critical sectors, the Act addresses key challenges related to regulatory compliance, data governance, model transparency, human oversight, and ethical use. It also defines requirements for conformity assessment, post-market monitoring, and documentation for high-risk AI systems. This framework supports the safe, trustworthy, and harmonized adoption of AI while ensuring protection of fundamental rights, patient safety, and public trust across the EU.

Course Syllabus

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

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

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

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

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

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

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

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

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

  1. Future Outlook + Global Impact​
  2. Concepts (part 1)​
  3. Concepts (part 2)​
  4. Healthcare + enterprise perspectives​
  5. What would you do?​
  6. Global AI compliance — regime comparison
  7. Implementation steps
  8. Top failure modes + penalties
  9. Key points to carry forward

  1. How this assessment works​
  2. Scoring + the credential​
  3. What your Certificate of Completion delivers​
  4. Apply the course — the first 30 days
  5. Completion slide​

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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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