09:00 - 09:30

• Welcome and registration

09:30 - 10:15

• Keynote: From scientific excellence to global leadership: Can the EU Biotech Act strengthen Europe's competitiveness in clinical research and innovation? - Aneta Tyszkiewicz (EFPIA)

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  Europe is at a critical crossroads. While it continues to produce world-class science, it is steadily losing ground to other regions in attracting clinical research, investment and the commercialisation of innovation. Against an increasingly competitive global landscape, the EU Biotech Act represents a unique opportunity to reverse this trend—but only if it delivers bold and meaningful reforms. This keynote will examine whether the proposed measures are sufficient to restore Europe's competitiveness, what further action will be needed, and how success should be measured to ensure Europe remains a global leader in biomedical innovation.

10:15 - 10:45

• Pragmatic clinical trials - Denis Lacombe (EORTC)

10:45 - 11:15

• Coffee break

11:15 - 11:45

• An update from the FAMHP - Anne Lenaers (FAMHP)

11:45 - 12:15

• An update on MDR / IVDR - Mieke Tempels (Archer Research)

12:15 - 12:45

• Potential of AI in drug discovery - Christophe Deben (Sightera Biosciences)

12:45 - 13:45

• Lunch

13:45 - 14:30

• Operational challenges when conducting clinical trials - panel discussion with Peter Bossuyt and Katrien Asnong (Imelda), Kathy Plachytka (freelance CRA), Virginie Barthel (NeoAlchemy Clinical), Dirk Meyssen (JnJ) and Katrien Tartaglia (ZOL)

14:30 - 15:00

• Towards a borderless Europe for clinical trial participation - Ingrid Klingmann (Pharmaplex)

15:00 - 15:30

• Coffee break

15:30 - 15:45

• Healixia Clinical Conference Award 2026

15:45 - 16:15

• Precision therapy logistics - J Verrept & F Van Gelder (at.las ATMP)

16:15 - 17:00

• Motivational keynote: Back on track - Thomas Van der Plaetsen (Back on Track Foundation)

17:00 - 17:45

• Closing drink