Problem Statement
The Global Substance Registration System (GSRS) is an open-source tool developed by the FDA, NIH, and EMA to track medicinal product ingredients and facilitate information exchange among regulators and stakeholders. Despite its benefits, the GSRS faces challenges such as limited stakeholder governance and financial instability.
Idea Proposal and Value Proposition
To address these issues, the proposal suggests forming a consortium of GSRS stakeholders, led by the Pistoia Alliance. This Consortium would govern the GSRS, develop a shared vision, create and execute a business plan, and oversee the system’s development and maintenance to ensure its future stability and harmonization of regulatory systems.
During this roundtable discussion, we will explore how the system is currently being used and identify opportunities to further its development and enhance its value for all stakeholders involved.
Host:
- Birthe Nielsen
Presenters:
- Jean-Gonzague Fontaine (GSK)
- Jeff Shick (USP)
- Tyler Peryea (FDA)
Register here