Fireside Chat with Emer Cooke, Executive Director, European Medicines Agency (EMA)

Join Emer Cooke, Executive Director of the European Medicines Agency and discuss how your innovation is supported to patients in the European Union. Topics will include:

• Accelerated and harmonised clinical trials – impact of the EU Biotech Act, how this is supported by initiatives and pilot programmes including ACT EU and FAST EU, plus early scientific Advice for innovators.
• Pathways for early innovation and biomanufacturing – introduction of regulatory sandboxes and interfaces with medical devices, early access to advice including for decentralised manufacturing and personalised medicine.
• Global alignment – working together across global regulatory regions, including on how AI works for innovation, and managing global supply chains.

The session is open to questions from the audience, so come to listen and then engage — all questions are welcome, with further support available at the European Pavilion (#2411).