Conversations on Today’s Priorities!
Thought-provoking, worldwide issues will be deconstructed by acclaimed panelists representing multiple stakeholders from around the world in this growing ecosystem of life sciences. DIAmonds represent rare opportunities to listen to open conversations on controversial topics such as owning health data, innovation in global health, and international regulatory collaboration.
EU Regulatory Townhall
The EU Regulatory Townhall, chaired by Anthony Humphreys - EMA’s Head of the Regulatory Science and Innovation Task Force, will look into the European Regulatory Framework, the challenges it is facing, opportunities on its way, and how can it develop to better support research and development in Europe.
Digital Transformation in Europe
This session will look back at the effects the new ways of working have had on the Digital Regulatory Business Transformation in Europe and its impact on stakeholders´ resources and planning.
Lessons Learned: What will be the “Lasting Legacy” of the COVID-19 Pandemic?
In this session, we will discuss how the lessons learned from the COVID-19 pandemic together with the extended mandate of the EMA may impact access to medicines and medicine shortages in a future pandemic setting, technology integration, joint clinical assessment, among many others.
How can we accelerate innovation in Clinical Trials in Europe? Could it be triggered by partnerships and collaboration? These and many other questions will be the explored in this session dedicated to this Clinical Trials’ transformation initiative.
Patient Generated Data - Does it Influence Decisions?
Patient’s involvement is becoming a fundamental principle throughout drug development and during regulatory advice and assessment. This session will bring together patients and various stakeholders to discuss the importance of patient-generated data and patient experience data to better assess “patient identified unmet medical needs”, practical implementation examples and next steps.
International Collaboration: Reliance in Action
This session will highlight practical experiences by regulators from around the world and industry, leveraging case studies showing different collaborative and reliance pathways and discussing critical factors to identify effective reliance models that enable efficient use of resources and faster access to medicines.
The European Health Data Space (EHDS): Can this Legislation Unlock the Power of Data to Stimulate Innovation in Europe?
In May 2022, the European Commission adopted the European Health Data Space (EHDS) legal proposal, aimed at increasing access to and sharing of health data within and across EU member states. This session will provide a holistic overview of where healthcare stakeholders and the audience stand on key issues related to the EHDS and its ability to truly “unlock the power of health data” in Europe.
Antimicrobial Resistance: Is it the Next Pandemic?
This DIAmond session will discuss the state of play and planned activities to combat AMR in Europe and on a global scale, and gain insights on the perspective and expectations of various stakeholders.
Policy and Healthcare Systems
If cost wasn't a barrier, what else would get in the way of medicines being used by patients? In this session, the various stakeholders will come together to explore inequalities and access barriers beyond cost impacting patient’s access to medicines and, ultimately, the sustainability of healthcare systems.
Information regarding the session chairs and detailed session summary to follow in September.
This Townhall will explore WHO’s activities, programs and efforts connected to Regulatory Systems Strengthening, and discuss their impact and implications on various stakeholders.
With the HTA regulation adoption in January 2022, a transition period has started, and the future EU HTA system is slowly starting to take its form. In this Townhall, the various stakeholders will discuss the most relevant aspects connected to its implementation, among other topics crucial in this path.