Internationalisation of read across as validated new approach method (NAM) for regulatory toxicology

Time: July 16th to July 18th 2018

Venue: Hotel Belvedere, Ranco (Lago Maggiore), Italy

Background

1. Read-across is a data gap filling technique used commonly as alternative to animal testing.

2. New approaches to improve the process and its regulatory acceptance are in high demand.

3. Important areas to be explored are the coupling of read-across to information from in vitro molecular screening, “-omics” assays and computational models.

4. Read-across is mainly used in Europe in the context of the REACH legislation, but further internationalization is urgently required to make the approach attractive for multi-national companies

Format

Attendance is by invitation only (closed session face-to-face meeting), focusing on extensive exchange of knowledge. Participants are expected to prepare a short statement (1-2 pages) on the topics to be discussed or the questions raised ahead of the meeting. Starting in the early afternoon on day 1 and close with a wrap up in the morning of day 3 (2 overnight stays). The location (Ranco, Italy) is close (3 km) to European Commission's Joint research Centre (JRC) which operates the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM). Break-out sessions are used to focus on specific topics. The CAAT think tank workshops are usually summarized in a position paper published in ALTEX (IF: 3.8).

Aims

1. Assembly of international experts to define the steps necessary to make read-across more consistent and standardized

2. Expanding the use and acceptance of the read-across to international regulatory agencies.

Agenda