BIORIMA aims to develop an Integrated Risk Management (IRM) framework for Nano-Biomaterials (NBM) used in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). The BIORIMA IRM framework is a structure upon which the validated tools and methods for materials, exposure, hazard and risk identification/assessment and management are allocated plus a rationale for selecting and using them to manage and reduce the risk for specific NBM used in ATMP and MD.
The BIORIMA IRM framework will be
- Robust and readily applicable to past and current generations of NBM because it is built on the large and growing database of evidence and experience of researchers in Nanosafety and Nanomedicine.
- Flexible, in its modular construction, which can easily integrate new scientific results to address the need of future generations of NBM.
- Beyond the state of the art for NBM safety by providing an encompassing and consistent framework applicable to both NBM and ENM. Specifically, the integration of knowledge from Nanosafety regarding Exposure/Hazard/Risk will advance the current status of NBM safety considerably. An unified IRM framework for both medicinal and engineered nanomaterials is clearly of tremendous advantage to the standardisation and regulation of these materials . The weight of evidence to support and the transparency in the implementation of the tools/methodologies will undoubtedly make the BIORIMA IRM framework an essential and invaluable contribution to the future development and sustainability of biomaterial technology.
The BIORIMA IRM framework will consist of:
- Validated methodologies and tools to identify the potential Exposure posed by NBM to humans and the environment.
- Validated methodologies and tools to identify the potential Hazard of NBM to humans and the environment, including a specific strategy for Intelligent Testing (ITS).