Last week, we had the pleasure of hosting a dynamic workshop in Barcelona at the CSIC- Residència d´investigadors, focused on the evolving regulatory landscape for products containing nanomaterials. It was an excellent opportunity for insightful discussions with stakeholders from EU-funded projects and industry experts, thanks to significant contributions from BSI and the Nanotechnology Industries Association.
Key Agenda Highlights:
- Introduction & Workshop Rationale: The workshop opened with an introduction to the Nabiheal and Phoenix projects and the rationale behind a shared regulatory approach, presented by Sergio Veiga (Asphalion) and Ivana Vinković Vrček (Institute for Medical Research and Occupational Health).
- Regulatory Landscape for Nanoparticles in Medical Devices: Presented by Francisco Rodríguez (Asphalion), this session explored the key regulatory aspects specific to nanoparticles in medical devices.
- Approval Process under MDR Rules 14 & 19: Godwill Iheagwaram from BSI shared his insights on regulatory pathways under Annex VIII, providing essential guidance for the approval of medical devices containing nanoparticles.
- Guidelines on Nanomaterials (OECD, ECHA, EFSA): Blanca Suárez Merino from the Nanotechnology Industries Association gave an in-depth presentation on existing and upcoming regulatory guidance for nanomaterials, applicable across sectors including chemicals, food, and cosmetics.
- Regulatory Framework for Nanoparticle-Based Medicinal Products: Daniel García from BNN covered regulatory processes specifically focused on nanoparticle-based medicinal products, a key area of innovation.
The event wrapped up with a roundtable discussion that allowed for in-depth dialogue on shared #challenges and bespractices across the nanotechnology and regulatory fields.
A special thank you to BSI (especially Godwill Iheagwaram and Pilar Maldonado), Blanca Suárez (Nanotechnology Industries Association), Fran Rodríguez from Asphalion, and Daniel García (BNN) for their invaluable contributions and expertise, which made this workshop a success.
Contact us for further information: [email protected]
