|Start:||Nov 23, 2023 - 8:00 am|
|End:||Nov 23, 2023 - 6:00 pm|
|Venue:||LNE, Paris (France)|
Dear ETPN members, dear colleagues, the LNE is organizing a workshop on nanomedicines and nanomaterial-based medical devices on Monday November 13, 2023 in Paris, at the Mercure Porte de Versailles Expo – Vanves hotel.
The international standardisation roadmap for nanomedicine
Nanomedicine and nano-enabled medical devices therapeutics (defined here as nanotherapeutics) are innovative solutions for tackling several health challenges, by delivering therapeutic agents to specific targeted sites in a controlled manner.
The international community recently started to work on the development robust and validated analytical methods, fit for purpose reference materials and formally recognised consensus standards for the assessment of their quality and safety.
Objectives of the day
The intent of the workshop is to:
- share information on existing (pre)-standardisation initiatives ongoing at the European and international level (OITB, Euramet, VAMAS, EDQM, ASTM E56, ISO/TC 229, CEN/TC 352)
- identify and prioritise specific measurement and standards needed to facilitate preclinical development and regulatory approval moving forward.
The workshop is co-sponsored by the 22HLT04-MetrINo project and the NanoMeasure France association.
If you are a member of the NanoMeasureFrance association, please contact us to register: email@example.com
09h00 | Welcome of the participants
09h25 | Introduction of the day
- Favre, Directeur Institut LNE Nanotech
Pre-standardisation activities : the EU perspective
9h30 | “Advancing characterization methods and standards for nanotechnology based medical products”
Dr. Luigi Calzolai, European Commission, Joint Research Centre (JRC), Ispra, Italy
09h55 | “The SAFE-N-MEDTECH-Open innovation test bed for Safety Testing In The Life Cycle Of Nanotechnology-Enabled Medical Technologies For Health”
Dr. Adriele Prina Mello, Trinity College Dublin
10h20 | “PHOENIX – Pharmaceutical Open Innovation Test Bed for GMP Manufacturing of Nanopharmaceuticals”
Dr. Nazende Günday-Türeli, MyBiotech GmbH
10h45 | “Multi-detector Field flow fractionation for liposomes and RNA-LNPs: from the lab to Standardization.”
Dr. Jeremie Parot, SINTEF Industry, Biotechnology and Nanomedicine department
11h10 | coffee break
EU metrology strategies and activities
11h40 | “International and EU metrology strategies and activities”
Dr. Paola Fisicaro, LNE (Laboratoire national de métrologie et d’essais)
12h05 | “MetrINo-Metrology for nanotherapeutics”
Dr. Fanny Caputo, LNE
12h30 | Lunch break
13h30 | Round-table part 1 : Industrial needs, identified priories
Ongoing Standardisation projects part 1
14h00 | “Overview of VAMAS interlaboratory comparisons relevant to nanomedicine and future outlook”
Dr. Caterina Minelli, NPL – National Physical Laboratory
14h25 | “Assuring quality of nanomedicines: activities at the European Pharmacopoeia”
Gerrit Borchard, School of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva, Switzerland
14h50 | “Standardising nanomedicine at ISO/TC 229: one particle at a time”
Denis Koltsov, chair of ISO/TC 229
15h15 | Coffee break
Ongoing Standardisation projects part 2
15h45 | “Total lipid quantitation in liposomal-based drug formulations”
Bryant Nelson, NIST – Material Measurement Laboratory, Gaithersburg, MD USA and ASTM International, E56.08 Subcommittee on Nano-Enabled Medical Products, Conshohocken, PA USA
16h10 | “Certified Reference Materials for Lipid-Based Nanocarriers”
Shan Zou, Team Leader for Nanoscale Measurement, Metrology Research Centre, National Research Council Canada
16h35 | Round table part 2 : How can EU be part of the game?
Define practical approaches for collaboration and harmonisation of activities among the metrology community and the standardisation bodies active in the field of Nano medicine at the European Level.
17h30 | End of the day
- Participation fee, including lunch on site: €120 excl.
- Exhibitor fee, including the possibility of displaying a roll-up: €150 ex VAT