DIAmond Sessions
Conversations on Today’s Priorities!
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Legacy Sessions
EU Regulatory Townhall – The New EU Pharmaceutical Legislation
The EU Regulatory Townhall will explore the proposed New EU Pharmaceutical Legislation, opportunities and potential challenges from the point of view of the various stakeholders.
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Regular Diamonds
Driving R&D to meet societal needs The session will bring together key players in the pharmaceutical innovation - developers, health and regulatory authorities, patients, among others - to discuss the challenges and opportunities in aligning R&D with evolving healthcare and societal demands, while aiming to inspire collaborative strategies to make it a reality.
Digital Transformation in EU Regulatory Space
Enhancing the collaboration across stakeholders is key to ensuring that digital transformation delivers on the expectations of all players and especially of patients. This session will focus on the concrete plans that have been made for digital transformation in the regulatory space for the next ten years, focusing on identifying interdependencies, challenges/blockers and potential synergies across these plans.
Complexity: Interplay and Interface of Different Legislations
As the EU landscape of policies and regulations governing medicines research, development and manufacturing becomes increasingly complex, with many products consisting of components regulated by different policies, this Session will shed light on the complexity of the interplay between pharmaceutical, food, chemical and environmental legislation and discuss recommendations how to avoid or mitigate potential negative impact.
ACT EU and the Future of Clinical Research in Europe
ACT EU aims to build on this and enable Europe to flourish as a global focus for clinical research, both in the development of new medicines and in the refinement of use of existing medicines. It aims to achieve this by optimising the EU environment, accelerating the trials by reducing unnecessary bureaucracy while strengthening delivery of decisional evidence, and enabling the evolution towards trials that are more innovative, patient centric and inclusive. In this session we will discuss actionable recommendations to accelerate the implementation of the vision for ACT EU and the transformation of clinical trials in Europe.
EU Regulatory Network Strategy
In this session, we will explore the EU Regulatory Network Strategy and discover the collaborative efforts and joint strategic initiatives from the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). Join us for a thought-provoking discussion on the latest developments, challenges, and future directions shaping the regulatory framework within the European pharmaceutical landscape.
Outlook and Opportunities of the EU Pharmaceutical Legislation on Value & Access
Innovation in Manufacturing and CMC
This session will focus on the global regulatory frameworks for enabling innovation in manufacturing and quality. Innovation includes the development and manufacture of new types of products, new manufacturing platforms, innovative technologies such as model-based controls, the wider scope of and new analytical technologies. The discussion comes at a critical time as the implementation of new digital tools and manufacturing technologies are key to the evolution of manufacturing, which can be enabled by tools such platform technology master files. The session will also reflect on how groups such as the new EMA Quality Innovation Group is seeking to lead the transformation of medicines’ manufacturing in Europe and how this is linked to fast moving initiatives outside of Europe, such as FDA FRAME and platform design technology programs, ICH and ICMRA collaborative initiatives under the PQKMS umbrella, including collaborative assessments. The discussion will also focus on how collaboration and the identification of risk can already enable technology.
Sustainability
This session will highlight the need for immediate change and encourage actions that reduce the environmental impact of healthcare. We will explore recent actions in the European policy and regulatory environment that accelerate sustainability and hear about ambitious measures taken by the Industry to reduce carbon emissions of drug production, lower the environmental impact of clinical trials, and develop metrics to benchmark their actions.
WHO Townhall
Regulatory systems strengthening activities play a crucial role in assisting countries in identifying and addressing gaps through the utilization of benchmarking tools. These activities also aim to enhance capacity, working towards achieving a more stable maturity level, specifically ML3, as outlined in WHA Resolution 67.20. As we approach 2024, a pivotal moment awaits the WHO Listed Authorities (WLAs) initiative, marked by the expansion of the WLAs network.
During the session, key elements of the WHO's regulatory system strengthening, WLA initiative, WHA75.8 resolution, and Antimicrobial Resistance (AMR) activities will be introduced. A comprehensive discussion will follow, exploring the impact and implementation of these initiatives in collaboration with various stakeholders.
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