MACRAMÉ Webinars on Harmonisation, Standardisation & Validation of Test- and Characterisation Methods

Webinar I:

Standardisation & Validation made simple

Understanding the role of metrology and standardisation to answer the regulatory requirements for advanced materials and nanomedicines

Presenters: Georges Favre (LNE), Caterina Minelli (NPL)

09.04.2024
14:00 – 16:00 CEST

Short Abstract, Programme & Recording

Metrology, method validation, standardisation… they are concepts that might sound complicated, but are essential in analytical sciences, since they strongly support the development of innovative products such as advanced materials or nanomedicine.

This Webinar aims to provide experienced researchers, but also young researchers, PhD students, and lab technicians the basis of metrology and standardisation. Information will be shared on important concepts (reference materials, SOPs, inter-laboratory comparisons…) and associated existing databases. The pathway to follow from the development of a standard operating procedure (SOPs) to a standard test method will be explained together with the role of national metrology institutes, metrology committees, standardisation bodies (ISO, ASM, CEN, VAMAS), and specific entities (e.g. the OECD, ICH, and EDQM).

Finally, two different cases of the maturity of this process will be described to illustrate the path towards validated and recognized methods in relation to nanomedicine and advanced materials. This knowledge is invaluable for increasing the impact of the protocols you develop beyond the academic community, and for keeping abreast of new standards and reference materials on the horizon.

BASICS OF (DEFINITIONS):

Metrology (terms and definitions of trueness, precision, traceability, ,….)
ILC / Proficiency Testing
SOP
Documentary Standards
Reference material
Databases (calibration and measurement capabilities, RMs, standard documents)
Accreditation according ISO/IEC 17025 standards

LANDSCAPE & OPPORTUNITIES

VAMAS
EURAMET & ENMs
CCQM
Standardisation: CEN, ISO, ASTM
OECD
ICH (norms for method validation), EDQM

Webinar II:

AOPs: A tool to include NAMs into regulatory testing?

Presenters: see the programme below

11.04.2024
14:00 – 16:00 CEST

Short Abstract, Programme & Recording

Regulatory safety testing of chemicals and materials is still mainly focused on animal testing. A huge number of New Approach Methodologies (NAMs) to replace or reduce animal testing have been scientifically developed within the last years. Their regulatory use, however, is still limited. A possible way to include NAMs into regulatory testing may be found in Adverse Outcome Pathways (AOPs). We will present what AOPs are, how they can be developed and established at OECD. The AOP for pulmonary fibrosis and the AOP on acute lung toxicity will serve as examples for the development of nanomaterial-relevant AOPs. We will discuss the implementation of AOPs into regulatory testing and hurdles.

Topics of the Webinar:

Overview of AOPs and their development
The AOP for Pulmonary Fibrosis: The first nanomaterial-relevant AOP en-dorsed
An AOP for acute lung toxicity including a NAM
Applicability of AOPs in (regulatory) hazard assessment

Agenda:

Moderator: Steffi Friedrichs

(technical) support: Elisabeth Heunisch

Time	Topic	Speaker
2:00 – 2:10	Welcome by MACRAMÉ and nanoPASS	Steffi Friedrichs (AIST)
2:10 – 2:30	Overview of AOPs and their development	Nathalie Delrue (OECD)
2:30 – 2:50	What is next for AOP173/AOP33?	Sabina Halappanavar (Health Canada)
2:50 – 3:10	An AOP for acute lung toxicity including a NAM	Jorid Birkelund Sørli (NRCWE)
3:10 – 3:30	Applicability of AOPs in (regulatory) hazard assessment	Qasim Chaudhry (University of Chester)
3:30 – 3:55	Q & A and Discussions	Blanca Suarez Merino (NIA)
3:55 – 4:00	Closing the meeting	Sean Kelly (NIA)

Webinar III:

Overcoming issues in regulatory testing of advanced materials

Presenters: see the programme below

04.03.2025
14:00 – 16:00 CET

Short Abstract, Programme & Recording

The 3rd webinar in the series of MACRAMÉ Webinars on Harmonisation, Standardisation & Validation of Test- and Characterisation Methods focussed on the topic Overcoming issues in regulatory testing of advanced materials.

The webinar organised by MACRAMÉ attracted over 40 international experts. A general introduction to standardisation and harmonisation of safety testing methods was provided. This training included an overview of the standardisation landscape, insights in the OECD documents and the process to develop OECD Test Guidelines. Then challenges in environmental and human health testing of advanced materials were shared with the audience. The participants were also invited to share their experiences via Mentimeter and interactive discussions during the webinar. Lessons learned from the work with nanomaterials were presented and are useful for the work towards safety testing methods for advanced materials. Potential solutions identified in MACRAMÉ to overcome the challenges in environmental and human health testing of advanced materials were explained.

Programme

Time	Topic	Speaker
14:00	Welcome	Anna Pohl (BAuA)
14:10	General introduction to standardisation and harmonisation of safety testing methods	Anna Pohl (BAuA)
	Challenges in human health and environmental testing of advanced materials
14:38	– Fish cells	Alberto Katsumiti (GAIKER)
15:03	– Daphinds	Iseult Lynch (UoB)
15:14	– Macrophages	Martin Wiemann (IBE)
15:27	Lessons learned from nanomaterials	Eric Bleeker (RIVM)
	Potential solutions to overcome the challenges in human health and environmental testing of advanced materials
15:32	– Fish cells	Alberto Katsumiti (GAIKER)
15:44	– Daphinds	Iseult Lynch (UoB)
15:54	– Macrophages	Martin Wiemann (IBE)
16:04	Summary and closing of the webinar	Anna Pohl (BAuA)