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

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.

Outlook:

BASICS OF (DEFINITIONS):

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

LANDSCAPE & OPPORTUNITIES

  1. VAMAS
  2. EURAMET & ENMs
  3. CCQM
  4. Standardisation: CEN, ISO, ASTM
  5. OECD
  6. ICH (norms for method validation), EDQM

AN EXAMPLAR JOURNEY FROM NEED TO STANDARD

EXAMPLES FOR ADVANCED MATERIALS – WHAT’S THE ALTERNATIVE FOR LESS MATURE CASES?

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

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)

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