Collaborative Registration Procedure Updates for Accelerated Access to IVDs
This update focuses on the Collaborative Registration Procedure (CRP) aimed at expediting the registration process for prequalified In Vitro Diagnostics (IVDs) by facilitating information sharing between the World Health Organization (WHO) Prequalification (PQ) program and National Regulatory Authorities (NRAs). The CRP involves voluntary participation of manufacturers of prequalified IVDs, ensuring product sameness, maintaining confidentiality of shared data, and setting a target timeline of 90 days for NRA decisions. Progress updates include published guidelines, signed agreements, and successful registrations through the CRP, showcasing the impact on various countries. The initiative aims to streamline the registration pathway for quality-assured IVDs, optimize resources across participating nations, and elevate regulatory efficiency in supporting public health goals.
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Presentation Transcript
Expanding the Ivory Tower Creating Educational Partnerships for Global Health
Dilemma: Engaging Students in Program Design Educational value beyond the transfer of essential knowledge
IH 744 Program Design for International Health- Objectives Learn essential elements of program design & proposal development Learn to translate evidence based results to action Build team skills & learn from each other Build confidence in professional skills
Expanding the Ivory Tower: Value Added Objectives Foster real world application of foundational knowledge Provide professional networking opportunities Form mutually beneficial practice-educational partnerships Add photo here
Small NGO Clear mission and objectives Willing to partner
Partnership in Action Student consultants to COHI Learned COHI s mission & priorities Researched areas for potential expansion Identified funding sources Researched, designed, & wrote program proposal Presented proposals to COHI
Our Partner: Circle of Health International (COHI) Mission: Working with women and their communities in times of crisis and disaster to ensure access to quality reproductive, maternal and newborn care Founded in 2004 by BUSPH Alum
Results of the Partnership: Our Partner s Perspective Provided potential programs for future work Continued support of COHI in a volunteer fashion amongst BU students Provided quality work that COHI could not complete, given limited means/personnel Allowed for positive feedback on current COHI projects and ideas for programming
Results of the partnership: Our students perspective BUSPH Summer Class Partners with NGO on Global Health Programming Fully engaged in the learning process Confident of newly acquired skills Achieved learning objectives Sofia Redford (left) and Joy Nolte present a poster of the program they created for Circle of Health International as part of the course IH 744: Design & Implementation of International Health Programs. The Boston University School of Public Health students enrolled in this summer's IH 744: Design & Implementation of International Health Programs course may have completed their class assignments and turned in their final projects, but their work may not be done just yet. For the course, students partnered with Circle of Health International (COHI), a non-profit that builds the capacity of women's healthcare providers in crisis settings around the world, to work as programming consultants for the organization. Their charge: design a program that COHI could implement in an international setting that addresses maternal mortality. The final outcome of their work could potentially be implemented on the ground by COHI. BUSPH The Insider, Michelle Salzman, June 2010
Student Feedback on the Course Real-world connection Having us develop an intervention program for COHI gave us all far greater incentive and ownership over the work we produced I really felt like a consultant and like what I was doing was important and valuable. This was learn-by-doing to its ultimate extent Multiple professional skills This class builds strengths of students on many levels.... a host of valuable skills that can and will be used in a professional life of a student Depth of student engagement suggest that students stock up their refrigerators, and make sure they have two-weeks worth of clean clothing because there will not be time to do much other than IH744 work
Academic Benefits Fully engaged & motivated students Meets practice-based criteria Opportunity to mentor students Students perform above & beyond the norm
Expanding the Ivory Tower: Application Fostering connections in the professional world Small businesses and organizations Benefit from the students work Willing partners mutually benefit both students and partners
Thank you! James Wolff jwolff@bu.edu Monita Baba Djara monitab@bu.edu Leilani Johnson - leilani@cohintl.org
