BIORIMA | 1st BIORIMA Stakeholder Workshop

1st BIORIMA Stakeholder Workshop

“Integration” was the underlying keyword of the 1st BIORIMA Stakeholder Workshop, which was held in the beautiful Spanish city of Valencia on November 6th 2018.

Over 40 participants from the regulatory, industry and academic research fields have gathered to contribute 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.

BIORIMA’s Final Public Event – Results, Reflections and Aspirations

A large audience of wide-ranging stakeholders logged on to take part in BIORIMA’s final public event, held on January 19th, 2022. Organised with polished efficiency by Lisa Bregoli and Stefania Melandri, Warrant Hub, the event comprised three distinct and engaging sessions: 1. Presentation of BIORIMA Final Results 2. Nanosafety projects response to real-world needs 3. NSC-community-activity “Brainstorming of future collaboration for nanobiomaterials risk assessment”

BIORIMA FINAL MEETING

The BIORIMA Project held its final meeting from 17th – 18th January, a large, well-attended gathering of project members from all partner organisations, the External Advisory Board, and Marcello Cacace, the Project Officer from the EC.

News from the BIORIMA Project

A safe and sustainable society and environment are the two pillars on which our future stands, and both have to be continuously supported and protected by transparent, long-sighted and science-based regulation that is shared by all actors involved. BIORIMA is contributing to these ongoing new regulatory needs by developing novel methodologies that help us to obtain the knowledge and tools to manage possible risks associated with emerging new materials, such as nano-biomaterials (NBM), when used in medical applications.

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