1st BIORIMA Stakeholder Workshop

Risk Assessment and Risk Management of Nano-Biomaterials in Medical Applications

6 November 2018, Valencia, Spain

Nanotechnology raises high expectations in healthcare applications such as nano-enabled Medical Devices (MDs) and Advanced Therapy Medicinal Products (ATMPs), in particular to rapidly advance the efficacy of imaging, diagnosis and therapy. Academic and industrial research in this field is continuously growing in relevance, but has been mainly focused on technological developments, while the safety aspects have received less attention.

Together with the increasing investments observed in this sector, there is also a growing need to develop an efficient approach for assessing and managing all the potential risks of nano(bio)materials (NBMs) along all stages of their life cycle, to ensure and improve their overall safety and promote the long-term sustainability of new products.

This workshop will provide a unique opportunity to share and discuss views and needs of stakeholders involved in the development, marketing, evaluation and regulation of new NBMs. The BIORIMA project is developing an overarching framework for risk assessment and management of NBMs used in MDs and ATMPs that is based on regulatory requirements, industrial needs and state-of-the-art scientific approaches and tools. The purpose of this workshop is to engage relevant stakeholders in an interdisciplinary dialogue to foster the development of such a framework and to integrate their perspectives and priorities, so that a shared vision on risk management of NBMs can be achieved and promoted.

Main topics of the workshop will in particular include risk-benefit analysis, occupational and environmental risk assessment and management, strategies for risk prevention, control and monitoring (incl. safer product and process design).

Key questions addressed:

Some of the key questions we will address are: What are the most effective strategies for risk assessment and management of NBMs used in MDs and ATMPs? What are the experience, needs and priorities of stakeholders in this field? How the future risk governance of NBMs should look like?

Stakeholders groups:

Industry, regulatory bodies, research/academia, manufacturing and healthcare workers, civil society organizations and any other organization involved in research & development, production, marketing, use, inspection, insurance, communication and decision-making on nanobiomaterials.

Agenda:

Session 1: Introduction

Welcome and introduction to the BIORIMA project
Lang Tran, Institute of Occupational Medicine
Introduction to the BIORIMA integrated risk management framework for
nano(bio)materials used in MD and ATMP
Danail Hristozov, Greendecision Srl
Risks along the lifecycles of nano(bio)materials used in MD and ATMP
Magda Blosi /Anna Costa, CNR-ISTEC

Session 2: Strategies for risk assessment

Occupational risk assessment
Elisa Giubilato, Ca' Foscari University of Venice
Environmental risk assessment
Janeck James Scott-Fordsmand, Aarhus University
Risk-benefit analysis for patients
Leagh Powell, Heriot-Watt University

Session 3: Strategy for risk prevention and control

Safety by molecular design strategies
Anna Luisa Costa, CNR-ISTEC
Safety by process design strategies
Terry Wilkins, University of Leeds
Risk reduction and control strategy
Carlos Fito, ITENE
Strategy for monitoring of emissions/release in occupational and environmental settings
Burkhard Stahlmecke, IUTA
Management of accidental risks from explosion and massive release
Alexis Vignes, INERIS

Session 4: Guided discussion

Strategies for human health and environmental risk assessment
Strategies for human health and environmental risk assessment
Strategy for risk prevention and control

Stakeholder panel discussion Moderator: Lang Tran, IOM

Workshop Flyer (PDF, 1.8 MB)