End-to-end diagnostics implementation: Advocating for innovative solutions скачать в хорошем качестве

End-to-end diagnostics implementation: Advocating for innovative solutions

24 February 2022, 15:00-17:00 CET Syndromic management based on clinical diagnosis with empiric treatment has been the mainstay of healthcare in low- and middle-income countries. Yet this excludes HIV and malaria rapid testing Slowly, appreciation for the clinical value of diagnostics is changing, but it remains suboptimal. The rapid development of tests for COVID-19 has taught us that sufficient political will, funding and resources can lead to success in a short time. The COVID-19 pandemic also taught us critical lessons that, if shared and adopted, can help us be better prepared for the next pandemic. To address some issues around research and development on innovative technologies for in vitro diagnostics (IVDs), the World Health Organization (WHO) developed the Collaborative Registration Procedure for the accelerated registration of prequalified IVDs based on its experience with procedures for prequalified medicines and vaccines. This procedure was successfully piloted in 2019 and is now being rolled out. In June 2021, WHO published further guidance to support the use of the registration procedure in the WHO Technical Report Series (TRS) 1030, 2021 (Annex 4). The Industry Liaison Forum, part of the Corporate Partnership Programme of IAS – the International AIDS Society – held a roundtable discussion bringing together representatives of regulatory and normative agencies and the diagnostics and pharmaceutical industry to introduce the collaborative procedure, particularly in low- and middle-income countries. They discussed the lessons learnt by IVD manufacturers and regulators from the COVID-19 pandemic and explored the Collaborative Registration Procedure.