Complement-ARIE Validation and Qualification Network (VQN)

The Validation and Qualification Network (VQN) is a component of the Complement-ARIE program that will accelerate regulatory approval and deployment of NAMs for biomedical research. The goal of the VQN is to work with regulatory authorities from other federal agencies, industry partners, and other collaborators to establish and apply validation/qualification frameworks to NAMs. The goal of these frameworks is to prepare newly developed NAMs to seamlessly enter into validation pipelines of regulatory authorities, paving the way for use on a broader scale by researchers in industry and biomedical research.  

The goals of the VQN include:

• Accelerate deployment and implementation of NAMs in both research and regulatory contexts.
• Develop standardized reporting and common data elements for preclinical, clinical, and safety performance.
• Perform conformity assessments and develop quality management systems.

By working with collaborators aimed at commercial market use and surveillance, the VQN will support the generation of data packages consistent with current validation and qualification frameworks to streamline submission of new NAMs to regulatory authorities. These data packages will be based on common data elements and standardized reporting, which will accelerate the deployment, regulatory qualification, and use of NAMs in the community.  

It is important to note, the VQN will NOT serve as the body that will validate and/or qualify any specific NAMs within regulatory contexts.  

U.S. federal agencies operate under statutes and regulations particular to each agency and therefore have different criteria for a NAM to be acceptable and applicable toward each agency's individual regulatory requirements.  In some cases, even within an agency (e.g. different centers of FDA) there may be different needs depending on the area of regulation.  Even though a NAM may be validated to address a specific endpoint for one (or multiple) context(s) of use under a particular guidance/regulation, it may not be considered acceptable under a different guidance/regulation among various agencies, regulatory jurisdictions, and countries.