CoRE and Duke-Kunshan Regulatory Strengthening Project Enabling Access To In-Vitro Diagnostics For Global Health Needs, in Collaboration with The Gates Foundation

Period

December 2024 - Ongoing

Project Objectives

Access to affordable in-vitro diagnostics (IVD) requires a myriad of enabling factors. Of which, regulatory systems play a pivotal role. Regulatory systems strengthening involves the entire ecosystem including regulators and industries, often with the support of global stakeholders. This project aims to

• Nurture and develop the IVD regulatory ecosystem
  

Conduct and nurture regulatory excellence through the engagement and training of both top-level executive management and functional staff in IVD companies and develop networks with international IVD regulators and global thought leaders.

• Convene global and regional thought leaders in IVD ecosystem to foster collaboration opportunities

Facilitate knowledge sharing and best practices to encourage IVD manufactures to accelerate market access of essential IVD for LMICs. Given the exponential growth of medical technology in Southeast Asia and Korea, the collaboration and networks will start with these countries before scaling to other LMIC countries in the future.

Project Outcomes

The activities will develop executive leadership skills and deepen regulatory knowledge for the diagnostics manufacturers and provide networking opportunities within IVD ecosystem in China, Republic of Korea and Southeast Asia. This will promote discussions among global and regional key stakeholders and facilitate access of affordable IVD to alleviate global health needs in LMICs. Through international roundtables, regulatory functional trainings and discussions among key stakeholders, international collaborations could be explored and initiated to enrich the global IVD regulatory ecosystem. 

Project Activities

A range of activities has been designed to engage different roles including executive leaders and functional regulatory staffing level. These activities aim to develop executive strategic leadership skills, deepen global regulatory knowledge and provide networking opportunities to facilitate alignment with global regulatory requirements and ultimately, improve access to global markets.