The recent HMA-EMA joint Network Data Steering Group meeting, held virtually, charted a critical course for future data standardisation and regulatory strategies under its purview. Lauded by stakeholders, the session marked significant steps by adopting final draft guiding principles for the use of AI in drug development, alongside refining strategies for data standardisation and patient registry integration for regulatory usage.
AI’s Role in Drug Development Rules
Joerg Zinserling from BfArM introduced the final draft of guiding principles to steer AI applications in drug development. Developed in collaboration with the US FDA, the principles received broad endorsement. This cooperation aims to harmonize terminologies between both agencies to ensure consistency. These pioneering guidelines are set to be published shortly and further discussed at the ICMRA summit later in the month. Endorsements received by CHMP also position these principles as scientific references for the future, emphasizing further guidance development.
Advancing Data Standards
Nick Halsey of the EMA delineated the data standardisation framework plan, emphasizing a need for pragmatic coordination. The framework aims to streamline network priorities, enhance collaboration, and efficiently allocate resources. This new structure also prescribes specific actions focusing on stakeholder engagement and regulatory process refining, promising to shape a comprehensive EU implementation guide. The proposal incorporates a decision-making flowchart, with NDSG’s endorsement paving the way for an actionable roadmap.
Key takeaways from the meeting inferred several action points:
- Immediate attention to align terminologies and frameworks for seamless data integration across stakeholder networks.
- Proactive roles for patient registry integration, where engagement, guidelines, and community building are primary focus areas.
- Formulation of training modules for widespread regulatory and stakeholder comprehension regarding AI and registries.
The meeting attendees concluded with an anticipatory look at future events. The upcoming sessions, including a December meeting and Annual Data Forum, will further refine these initiatives, incorporating biostatistics, digital twins, and synthetic data innovations. The ongoing collaborative ventures underscore the commitment to evolve with technology while remaining steadfast in enhancing data standardisation and regulatory compliance. Stakeholders should engage actively in these discussions to effectively leverage upcoming advancements in regulatory science, ensuring that strategies remain robust and effective amidst the evolving pharmaceutical landscape. Such ongoing efforts highlight the importance of steadfast collaboration and dynamic adoption of technological advancements to meet future challenges.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
