Agenda for Day 3 - Wednesday 11 November, 2026
European Health Data Space: sharing digital patient data
GDPR, anonymization, and secondary use of data considerations
How does the AI Act interact with GDPR, particularly regarding the use of patient data in AI models?
Addressing global data-sharing challenges and regulatory considerations
- Niklas Blomberg - Executive Director, Innovative Health Initiative
Update on Darwin Project: full data pilot for non-interventional studies
Member States’ independent approaches to RWE and its impact on EU-wide consistency
Intersection of Darwin and EHDS: navigating global transparency and data-sharing challenges
Addressing regulatory questions in pre- and post-marketing spaces with RWE
- Almath Spooner - Head of Europe Regulatory Policy & Intelligence (RPI), AbbVie
What specific regulatory obligations will companies need to meet under the AI Act?
How will the regulatory burden of the AI Act impact innovation in drug discovery and development?
EMA and FDA common principles for AI in medicine development
Impact of the AI Act and EMA & FDA common principles on the use of AI in drug development and clinical trials including patient recruitment, monitoring, and data analysis
- Mariam Jamali - Head of Regulatory Affairs Iberia & Regulatory Policy Manager, Bayer
Impact of Biotech Act changes on product development and regulatory timelines
Adapting to combined assessments for notified bodies
Addressing delays and inconsistencies in device and diagnostic approvals
Ensuring compliance with updated MDR and IVDR requirements while fostering innovation
Navigating market access and competitiveness for advanced therapies and diagnostics in Europe
Key industry learnings from Joint Clinical Assessment procedures
Addressing legal challenges and rare disease economic models
Understanding Member States’ early responses to HTA implementation
Evaluating whether HTA regulation will streamline market access or introduce new hurdles
- Inka Heikkinen - Regulatory Policy Lead, Director, Lundbeck