The first BIORIMA Stakeholder workshop was held in the beautiful Valencia on November 6th 2018, titled: “Towards an Integrated Risk Management Framework for Nano-Biomaterials used in medical devices and advanced therapy medicinal products”.
“Integration” was the underlying keyword of the meeting, where over 40 participants from the regulatory, industry and academic research fields contributed to the interdisciplinary dialogue and to develop a shared approach for understanding and managing risks of Nano-Biomaterials (NBM) used in medical devices (MD) and advanced therapy medicinal products (ATMP).
The workshop was planned as a forum for sharing knowledge and perspectives on risk assessment and management through all life cycle stages of NMB and represented a unique opportunity to discuss latest regulatory and scientific issues of NBM risk management. During the workshop, the aims and characteristics of the BIORIMA risk management framework were presented, together with an overview of target NBM and their biomedical applications considered in the project.
The proposed strategies for human health and ecological risk assessment, benefit-risk assessment, risk prevention and control of NBMs were illustrated, and different aspects of the framework and its strategies were discussed among participants.
This workshop was instrumental for the BIORIMA project, aimed to develop an overarching framework for risk assessment and management of NBM used in MD/ATMP. The inputs from stakeholders will allow BIORIMA to provide a tool which is truly based on users needs as well as regulatory requirements and scientific knowledge, to SMEs and industrial manufacturers in Europe and beyond.
For further information about the project, please visit our website at www.biorima.eu.