December 16, 2024
IPOPI took part in the HMA*/EMA hosted a multi-stakeholder workshop on Artificial Intelligence (AI)
As part of IPOPI’s AI Rare LEX project and its ongoing efforts to explore the potential of AI-driven technologies to enhance PID diagnosis and care within a well-regulated framework, IPOPI participated in the HMA/EMA multi-stakeholder workshop on Artificial Intelligence (AI).
On November 5, 2024, the HMA/EMA convened a pivotal multi-stakeholder workshop on Artificial Intelligence (AI), gathering experts, policymakers, and patient and industry representatives to address the transformative role of AI in healthcare and its integration across the medicine lifecycle. The workshop provided an opportunity to showcase the latest advancements in AI through keynote presentations and offered stakeholders critical updates on the evolving policy and legislative environment, including the revision of the AI Reflection Paper.
A significant aspect of the discussions focused on the HMA/EMA multi-annual AI work plan. Stakeholders reviewed its progress and considered potential updates to ensure that it remains adaptive to fast-paced technological changes. Additionally, real-world AI use cases were explored to highlight both opportunities and challenges, from drug discovery and development to post-market surveillance and patient care.
The workshop underscored the importance of international regulatory cooperation, particularly between the EMA and FDA, in creating a harmonised global framework for AI in healthcare. Such collaboration is vital to managing the complexities of AI adoption, ensuring consistent standards, and facilitating innovation without unnecessary barriers.
For Europe, finding the right balance between fostering innovation and maintaining robust regulation was a recurring theme. As the global race to integrate AI into healthcare accelerates, striking this balance is essential for Europe to remain competitive while safeguarding patient safety and ethical standards. The workshop reaffirmed the need for regulatory frameworks that are flexible, forward-looking, and supportive of technological advancements, ensuring that Europe continues to lead in the responsible use of AI in medicine.
HMA*: Heads of Medicine Agencies is a network of the heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area
** LEX Learning Expedition
