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… These concepts may sound complicated, but they are essential in analytical sciences. They strongly support the development of innovative products such as advanced materials or nanomedicine.

This webinar aims to help increase the impact of the protocols you are developing beyond the academic community and to get you updated on the new standards and reference materials on the horizon.

The webinar will inform on important standardisation concepts like 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. We will also elaborate on the role of national metrology institutes, metrology committees, standardisation bodies (ISO, ASM, CEN, VAMAS), and other relevant bodies (e.g. the OECD, ICH, and EDQM).

Finally, we will bring you up to date on ongoing activities in the field with a specific focus on nanotechnologies, advance materials and nanomedicines.

Outlook:

Basics of (definitions):

  1. Metrology (terms and definitions of precision, traceability, trueness,….)
  2. SOP
  3. ILC
  4. Documentary Standards
  5. Reference material
  6. Databases (calibration and measurement capabilities, RMs, standard documents)
  7. Summary and pathway to standardisation explained
  8. What to standardise (materials, methods, vocabulary and definitions)

Brief presentation of existing committees and their roles:

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

Examples of ongoing activities for advance materials:

Summary of the activities presented during the Macrame workshop, day 2 (graphene)

Examples of ongoing activities for Nanomedicine

[…]

Webinar II:

AOPs: A tool to include NAMs into regulatory testing?

Presenters: TBC

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

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