[EQ] Global health diagnostics: research, development and regulation

Global health diagnostics: research, development and regulation

Workshop report

 

UK Academy of Medical Sciences, 2009

Available online at: http://www.acmedsci.ac.uk/download.php?file=/images/project/Diagnost.pdf

 

Website: http://www.acmedsci.ac.uk/p47prid65.html

“…….The report highlights challenges and opportunities for research, development and regulation of diagnostics pertinent to low- and middle-income countries, with a focus on rapid diagnostic tests for infectious diseases. In particular, the report considers: the design and development of diagnostic tests; access to diagnostics; use of diagnostics in practice; regulation and evaluation of diagnostic tests; and challenges and opportunities for the diagnostics industry.

To date, efforts to address the burden of infectious diseases in low- and middle-income countries (LMIC) have largely focused on the development and delivery of vaccines and therapeutic interventions, whilst the importance of diagnostics has been comparatively neglected. …”

“…..Bringing these themes together, the report highlights the need for capacity strengthening in research and development, a greater focus on the priorities and contexts of LMIC during the design of diagnostics, and a tightening of regulatory requirements - potentially through a World Health Assembly resolution. The report also highlights scope for the development of a single body, involving academia, industry and relevant stakeholders, which could provide leadership and guidance on behalf of the diagnostics community, and contribute to the implementation of regulatory policy….”

Content:

1. Background

2. Introduction

3. Design and development of diagnostic tests

4. Access to diagnostics

5. Use of diagnostic tests in practice

6. Regulation and evaluation of diagnostic tests

7. Challenges and opportunities for the diagnostics industry

Conclusions

 

 

 

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