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This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!
Until a few years ago the trending hashtags were blockchain, real world evidence, and accelerated pathways. Soon after, Parallel advice and HTA Bodies, and Payors came to the fore, suddenly out of nowhere the world was hit with Generative AI. Let’s face it, the healthcare industry never had issues in keeping up with the times and health agencies are no different. Both FDA and EMA have issued guidance relating to the use of AI in 2023. This year the Agencies have also started implementing generative AI in-house. This session aims to shed light on the Agencies’ approach to balancing the need for swift access to groundbreaking treatments with the imperative of ensuring public safety. By fostering an open exchange of ideas, the chat will provide insights into the agencies’ current initiatives, their future directions, and the broader implications for public health policy and practice. Join us for a compelling conversation that promises to deepen our understanding of the complexities at the intersection of healthcare innovation and regulation, and to envision the future of public health in a rapidly evolving landscape.
Electronic Product Information (ePI) holds critical medicinal product information available to patients and healthcare providers almost in real time. Discover current state and factors needed for EU implementation and the overview of the EMA/HMA ePI Pilot Project. Session Leaders:
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How to successfully navigate the new EU HTA Regulation’s mandatory assessment of relative effectiveness occurring in parallel with MAA – earlier consideration of HTA evidence needs during clinical development and regulatory strategy will be key. Session Lead:
Focus of the session will be on practical implementation of the Clinical Trial regulation post transition in a global context. Experience will be shared from usage of CTIS including transparency and disclosure requirements. The session will discuss challenges in navigating between the different EU regulations in relation to clinical trials and elements to consider in navigating a global trial beyond the current fragmented environment. Session Leaders:
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