Agenda for Day 3 - Wednesday 11 November, 2026
- Examine how NAMs can help accelerate drug discovery, streamlining development timelines, and open new pathways for regulatory decision-making. Understand the current NAMs landscape and the role of NAMs in reshaping biomedical innovation.
- Explore the European funding opportunities for driving human-relevant modelling: from organ-on-chip platforms to AI-enabled digital twins.
- Steps for regulatory acceptance: understanding the principles of a well-defined context of use, the evidence required to demonstrate fitness for purpose and available routes for regulatory interaction, from early advice and support mechanisms to qualification.
- Propose practical approaches and priority actions to strengthen the NAM ecosystem.
- Philip Hewitt - Global Head of Early Investigative Toxicology, Merck
- Milena Mennecozzi - Project office, Joint Research Centre, European Commission
- Ole Olesen - Directorate-General for Research & Innovation, European Commission
- Joana Portela - Translational Sciences Office, European Medicines Agency
- How can regulators and industry create sufficient regulatory certainty to enable AI innovation?
- What specific regulatory obligations do companies need to meet under the current regulatory framework? How do they impact innovation in drug development?
- Regulatory convergence: EMA and FDA common principles for AI in medicine development
- Regulators as AI users
- What would an innovation-enabling regulatory ecosystem look like?
- Hilary Jones - VP Legal, Regulatory and Commercial Law, Consultant and formerly BioNTech
- 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
- Olga Van Grol-Lawlor - Global Regulatory Policy & Advocacy Associate Director, Boston Scientific
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
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
- Matias Olsen - Associate Director, Public Affairs & Policy, EUCOPE