Enable the responsible use of AI and thereby support business success
Led the design of a global AI governance framework for a leading pharmaceutical company, with a key responsibility of defining the risk management process for AI compliance, ensuring seamless integration with the current organizational structure and existing governance bodies
at a glance
Company Size
global market leader
Location
Germany
Period
03/25 - 05/25
Industry
Life Sciences
Main Services
AI Governance
Designing an AI governance framework
enabling regulatory compliance
01
Challenges
- EU AI Act requirements : The EU AI Act mandates transparency and accountability, highlighting the importance of a comprehensive governance approach to meet these obligations
- Anticipating future regulatory frameworks : Organizations must proactively prepare for upcoming compliance requirements from entities like the FDA to ensure they stay ahead of regulatory changes
- Privacy implications : The reliance on extensive personal data in AI systems necessitates clear governance to address privacy risks and protect individual rights
- Mitigating legal and reputational risks : A governance framework helps navigate complex data protection laws, reducing potential liabilities and safeguarding the organization’s reputation
02
Procedure
- Legal Requirement Analysis: Collaborated with legal experts to comprehend the implications of the EU AI Act and other relevant regulations
- Existing Compliance Assessment: Reviewed the current legal and compliance frameworks within the organization to identify existing structures and gaps
- Compliance Requirement Definition: Derived specific compliance requirements needed to align with the EU AI Act, ensuring clarity on obligations and standards
- Holistic Risk Management Process: Defined a comprehensive risk management process to evaluate AI-related risks and establish mitigation strategies
- AI Inventory Development Approach: Developed a structured approach to create an AI inventory, facilitating transparency and oversight of AI applications across the organization
Results
- Stakeholder Buy-In: Created a SteerCo deck to secure commitment for future phases and funding
- Regulatory Compliance: Implemented measures to validate adherence to legal requirements
- Governance Framework: Established a governance structure outlining key roles and responsibilities
- Risk Management Proposal: Developed a proposal for a global risk management process addressing AI-related risks
- AI Inventory Approach: Defined an approach for establishing a comprehensive AI inventory
Project Highlights
01
Secured stakeholder buy-in for future scope and resources, establishing clear accountability for the AI function within the organization
02
Developed a flexible risk management process to adapt to evolving local regulations while ensuring compliance
03
Prepared an AI inventory questionnaire and minimum viable product (MVP), enabling immediate kickoff in the next project phase
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