Multinationals are struggling to establish global measurements of ARMMs due to a lack of a cohesive worldwide approach. National regulations are often imprecise and based on a country-centric mindset. So, it is a real challenge for the MAHs to address on a global scale, particularly outside Europe. At Roche, we take a two-dimensional approach to safety risk management. An aRMM operates on a local spectrum but, at the same time, also contributes/responds to a global scale of benefit-risk balance. 
This led us to create a model that can unite both dimensions into an integrated Global-Local model to measure the effectiveness of ARMMs and ensure that ARMMs contribute to the benefit-risk profile, safeguarding patient safety globally, in alignment with Module XVI, Revision 3.
This model addresses historical challenges by incorporating early planning, efficient data collection, and global applicability based on the principles of reliance.
 

Enhancing Global Patient Safety: Roche's Integrated Global-Local Model for Evaluating the Effectiveness of Additional Risk Minimization Measures (aRMMs)

Collaborating for Healthcare Innovation – a focus on Sustainability!

18-20 March 2025
Basel, Switzerland

DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.

Join us in the vibrant city of Basel for an unforgettable experience, where the power of collaboration will be on full display to inspire actionable outcomes and mobilise for solutions the life sciences’ community. Witness first-hand the profound impact of united efforts, gain valuable insights from across the drug development lifecycle, and play an active role in shaping the future of the pharmaceutical arena.

DIA Europe 2025

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.