AN AWARENESS EVENT Current Status of New Approach Methodologies (NAMs) for Regulatory Purposes

Event Date: November 22nd - 23rd 2021

The event will aim to increase awareness and understanding of current and near future international regulatory developments for NAMs for chemical hazard and human risk assessment. The event specifically addresses BTS and IGHRC training requirements in raising awareness and understanding of the current status ¹ of the internationally-accepted regulatory science basis. This event will introduce the efforts of the FSA/COT strategic thinking on their Road Map towards the introduction of NAMs, along with the current scientific status of many NAM OECD test guidelines, and guidance in development.
This awareness event is suitable for and intended to bring together UK government scientists, risk assessors, risk managers, and policy makers together with BTS regulatory section members, academic test method developers, CROs, industry sectors and relevant NGOs.

This two-day event is open to all IGHRC and BTS members and will be held virtually on the 22nd and 23rd November 2021 from 10am-3.30pm.
There is no charge for participation.

To register please click HERE.

The majority (approx. 70%) of internationally-accepted NAMs being developed currently as test guidelines (TGs) in the OECD Test Guideline Programme (TGP) are for human health endpoints, and around 30% are in relation to ecotoxicological endpoints. The OECD TGP oversees the internationally harmonised test method and TG development for all OECD member countries. All of these TGs enable the results  to be covered by the Mutual Acceptance of Data  (MAD) system, when used in laboratories that are GLP certified, and can be used for the different regulatory data submission packages in OECD member countries.
This initial awareness event will focus on human health endpoints and will explore the following underlying themes:

  • Regulatory hazard assessment requirements and processes by which they are approved and improved.
  • Strategic thinking in the UK for the introduction of NAMs – how to take forward NAM methodology in the UK: The FSA/COT Roadmap.
  • Science and technological developments, what are regulators and end user’s needs?

Speakers are drawn from national and international sources and are leaders in their field to ensure that current status and regulatory applicability are addressed.

Preliminary Outline programme:

Day 1 – November 22nd 2021 Day 2 – November 23rd 2021
Introduction by the Chairs – Len Levy (IGHRC) and Miriam Jacobs (BTS/UK HSA)   Introduction by the Chairs – Len Levy (IGHRC) and Miriam Jacobs (BTS/UK HSA)
Aspirations Genotoxicity – endpoints
Regulatory in-vitro test method design Non-genotoxicity – endpoints
GLP needs for in-silico Mutual Acceptance of Data Overarching issues
In silico tool/QSAR reporting format development Round table discussion
Skin sensitisation – endpoint
Round table discussion
¹ A further workshop (‘Forward look, what different regulatory sectors need from NAM developments’) is planned by BTS/NC3Rs in early 2022 which will take a forward looking view at developments in the field of NAMs.