• to execute a “proof of concept” evaluation of whether selected facilities can perform according to current global standards and therefore to definitively determine if they are ready to conduct this work for western clients.
• provide “western industry” input to the SFDA on related regulations and policies based on consensus views gained from the experience with the studies
• opportunity for each collaboration member to establish productive long-term relationships with identified leading organizations.

This project will be based on the placement of a comprehensive set of approximately five evaluative animal safety studies conducted over a 9 month interval at the China-based preclinical safety labs judged as most capable in CHA’s recently completed China Tox Evaluation project (see Background). Other laboratory facilities may be included in the evaluation based upon participating companies’ requests. These evaluation studies will cover a range of timeframes, expertise, and species. The conduct of these evaluation studies will be closely monitored on a regular basis by CHA to judge the lab’s ongoing performance; and outcomes will be carefully evaluated to ensure a complete and accurate assessment of each institution’s operating strengths and weaknesses.

This project is designed to be collaborative, and thus facilitated peer-to-peer discussion and learning across both member companies and the evaluated facilities, will be at the foundation of the entire process.

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Background

Drivers

Project Benefits

Deliverables

Project Investment

Project Stages

Proposed Study Design

Project Leadership

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