Welcome to the BIORIMA Forum!
BIORIMA is developing an Integrated Risk Management Framework for Nano-BioMaterials used in medical devices and advanced therapeutic medicinal products. This forum is a discussion platform, where you, as an end-user or stakeholder, can directly engage with the project, exchange and share your views and ideas with our experts, or just give us your feedback on issues relevant for your business and work. How to use this forum: To send a post on the BIORIMA forum, you will need to register first by using the menu link “Register” below on the right. Once your registration is confirmed, you can click on one of the topics below and then post your feedback, comment or question directly by using the NEWTOPIC button. If you have any issues, please email Lesley Tobin: Lesleytobin@hotmail.com.
BIORIMA Webinar - Thursday 15th October Integrated Risk Management
We're delighted to invite you to take part in a free, interactive webinar this Thursday 15th October at 10.00-11.00 or 16.00-17.00 (CEST) in which we will explain the background of the BIORIMA project and the purpose, principles and potential applications of the Integrated Risk Management framework and the Decision Support System we are developing.
About the webinar: These short sessions will provide an opportunity for you to find out more about the EU-funded BIORIMA project and how you and manufacturers and users of Nano-Biomaterials (NBM) and associated Medical Devices (MD) and Advanced Therapeutic Medicinal Products (ATMP) can benefit from its output and results.
To evaluate the performance of the IRM framework, we have prepared a short real-time questionnaire to find out from you and other participants about the need for this type of IRM framework and DSS, and how you envisage applying such a specific tool in your daily research and/or business, for example, to improve internal processes or to comply with existing regulatory demands.
Webinar Agenda: Welcome to the Webinar (5 mins) Introduction to the BIORIMA project (10 mins) Integrated Risk Management (IRM) remote validation (20 mins) Conclusions and remarks (10 mins) End of the webinar
Abstract The European Medicines Agency (EMA) regards the potential risks of human medicinal products to the environment and their impacts are assessed, as well as management to limit this impact. Hazard assessment of novel materials, which differ from conventional chemicals, e.g. nanobiomaterials, poses testing challenges and represents a work in- progress with much focus on the optimization of required methodologies. For this work-in-progress, we here highlight where changes/updates are required in relation to the main elements for international testing based on OECD guidelines, supported by knowledge from the nanotoxicity area. The outline describes two major sections, nanobiomaterials and environmental hazards, including its challenges and learned lessons, with recommendations for implementation in OECD guidelines. Finally, the way forward via a testing strategy is described.
The latest NanoSafety Cluster Newsletter is out now and attached to this post. Items of interest include a report by Terry Wilkins, University of Leeds, on Safe-by-design of fabricated nano-enabled replacement hip joints (p30) and important updates on NanoTox2021, including links for abstract submission, registration and programme information.
Nanosafety Training School - From Basic Science to Risk Governance - REGISTRATION DEADLINE APPROACHING
Interprofessional Education Training School & Young Scientist Forum 2020
22 - 27 March 2020, Venice, Italy
This year the Venice Nano Training School celebrates its 10th anniversary. The Training School, organised within the EU funded Horizon 2020 projects BIORIMA, GRACIOUS, NanoInformaTIX, PATROLS, NANORIGO, RiskGone and Go4Nano will take place in San Servolo (Venice, Italy) on 22th – 27th March 2020.
The school will feature keynote speeches, hands-on sessions and a dedicated Young Scientist Forum Day (23th March) during which early career researchers (PhD students, PhD candidates and Post-Docs) will have the opportunity to present their work. Abstract submissions opened on 10 Dec.
The School week will include a variety of hands-on sessions aimed to transfer state-of-the-art knowledge on a variety of topics from key experts to the new generation of nano-environmental, health and safety, and biomedicine professionals, using interprofessional education.
Variety of networking activities (a welcome cocktail and a social dinner) will enable plenty of time and opportunities for you to widen your network and foster academic exchange.
Become part of an interactive, exciting week and enrich your knowledge by developing multidisciplinary expertise!
Who should attend? Early-stage researchers PhD students and Post-Docs Senior researchers Industry Governmental Agencies Medical Personnel Anyone interested in Safe Nanotechnology, Risk Assessment and Nano-Medicine
School Topics Hazard to Human Health & Environment Fate & Exposure Assessment Nanomedicine: from the lab to the market Modelling Grouping & Read Across Approaches Risk Governance School Location The training school will take place in San Servolo (Venice, Italy). The School will start at 15.30 CET on 22 March will end on 27 March the School will end at 13.30 CET.
DEADLINES Abstract submission closes on: 17th January 2020 Notification of accepted abstracts: 30th January 2020 Deadline for registrations: 20th February 2020
School Certificates Each participant will be given a certificate of attendance upon request.
“BIORIMA* activities are progressing successfully! The mid-term report on activities gives us full confidence in the project's ability to achieve the ambitious goal of providing an Integrated Risk Management framework for nano-biomaterials (NMB) used in advanced therapy medicinal products and medical devices.” Essentially, this is a summary of the General Assembly meeting which took place in Rome on November 5-6th at the CNR premises (National Council of Research, a partner in BIORIMA and the local organizer of the meeting).
All workpackages are progressing in line with timescales, including the development of tools for materials characterization, fate and exposure analysis, testing for human and environmental hazard, risk assessment and management, considering the whole life cycle of NBM: from production, to use, up to disposal.
On November 7th, immediately after the General Assembly meeting, the first BIORIMA decision support system (DSS) prototype was shown to a group of stakeholders from industry and regulatory institutions during the second “BIORIMA Stakeholder Workshop” at the premises of Università Tor Vergata (in Rome) - a partner in BIORIMA. Fruitful discussions with stakeholders confirmed that BIORIMA is committed to delivering an integrated risk management framework which is tailored to industry users and their needs, as well as being in line with regulatory demands.
The next key events and dates for the public are: the third BIORIMA training school, 2020. This will be organized together with other 6 EU-funded projects and take place during March 22-27th); and the General Assembly meeting with a public stakeholder workshop, which will take place later in the year in Venice.