Session (CTI)

Europe's medicines regulator is operating in an increasingly complex environment. Implementation of the EU Health Technology Assessment Regulation, rapid advances in artificial intelligence, geopolitical uncertainty, evolving expectations for scientific transparency, and growing pressure on public institutions are reshaping the landscape in which regulatory decisions are made. This exclusive conversation with the EMA team leaders will provide a rare inside view of how the European Medicines Agency is responding to these challenges while remaining committed to its core mission of protecting public health through scientific excellence. Laura Pizzi, Chief Science Officer of ISPOR, will lead a dialogue with Michael Berntgen, Francesco Pignatti and Dominik Karres addressing the Agency's strategic priorities, how leadership is balancing finite resources against expanding responsibilities, and the opportunities that lie ahead for regulatory science in Europe. The conversation will explore how the EMA is implementing the EU HTA Regulation and strengthening collaboration with HTA bodies, while also addressing broader issues that will shape the future of medicines regulation—including the responsible integration of artificial intelligence, maintaining public trust in science, responding to an increasingly complex geopolitical environment, and fostering international collaboration with partners such as the US Food and Drug Administration (FDA) and the International Council for Harmonisation (ICH). Designed as an interview rather than a technical update, this session offers attendees an opportunity to hear directly from a few of Europe's foremost regulatory leaders about the strategic decisions shaping the Agency today and the future of medicines regulation tomorrow. The conversation will conclude with audience questions, allowing participants to engage directly with the participating EMA staff on the issues defining the next era of regulatory science.