Innovate: The MedTech Series – The 2024 EU (European Union) AI Act Training Course

Part of Innovate – The MedTech Series series:

Overview

In August 2024, the European Union (EU) approved the Artificial Intelligence (AI) Act, the first legislation aimed at regulating AI applications whilst protecting EU citizens from the potential harms of AI. The regulation will take effect on 2nd August 2026 and will have a significant impact on the healthcare sector.

Legislative changes are also afoot across the globe. In the US, the FDA continues to update its guidance on AI-enabled device software. For example, in December 2024, the FDA published new guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for AI-Enabled Device Software Functions to provide a reasonable assurance of device safety and effectiveness  Conversely, Asia-Pacific has adopted a light touch and voluntary approach to AI regulation, some jurisdictions like China have taken a more prescriptive approach.  

According to a recent survey from Norstella, 66% of biopharma organisations say the skills required for their employees have changed due to the introduction of AI. Over 70% of industry leaders confirmed the main reason behind its limited adoption is a lack of expertise, followed by 43% having a lack of knowledge/awareness of AI and what it can do to improve pharmaceutical R&D processes. This session will summarise the European AI Act and its implications on the healthcare sector and what provisions and assessments organisations may need to put in place to be compliant with the new regulatory framework.

Key topics covered in this exciting talk include:

• An overview of the AI Act, the EU’s Coordinated Plan on Artificial Intelligence, and its potential impact on the healthcare sector
• A look at what constitutes a high-risk AI system and provide examples of where this might impact the pharmaceutical drug development and medical device commercialisation strategy
• Discuss the minimum information regulators will require for Fundamental Rights Impact Assessments (FRIAs) and Data Protection Impact Assessments (DPIAs) and what measures organisations need to put in place to ensure they are fully compliant with the protection of personal data

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

This course provides greater clarity on the potential impact of the AI Act on pharmaceutical and medical device organisations and brings stakeholders up to speed on what constitutes high-risk AI systems. By joining, you will: 

• Review the definition of AI and high-risk AI systems and provide real case studies where high-risk AI systems are utilised by pharmaceutical companies in the drug development process and medical device manufacturers in product development
• Gain a greater understanding of what the AI Act covers and what provisions and assessments organisations may need to conduct to be fully compliant with the new regulations
• Explore the implication of the EU AI Act on data protection and privacy and review the similarities/differences and information requirements for Fundamental Rights Impact Assessment (FRIA) and Data Protection Impact Assessment (DPIA) that organisations need to adhere to remain compliant

Who should attend?

This course is designed for a diverse audience. Whether you're a healthcare professional, a policymaker, or interested in how the EU AI Act will impact the healthcare sector, this course will offer you valuable insights.

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