This activity is specifically designed for:
Regulators
At the end of the course, learners should be able to:
Perform critical reviews of clinical performance studies and assessment of risks and benefits of tests for COVID-19 and other infectious diseases
Participate in a community of practice to share best practices and updates on regulatory science with a view to accelerating regulatory review and approval
Regulatory science needs to keep pace with technological innovation but determining whether these diagnostic tests are safe, effective and fit for purpose has become increasingly complex. Addressing these issues, the agenda is as follows:
Measurements of diagnostic test performance and effectiveness
Difference between evaluation, validation and verification
Key considerations in assessing clinical performance studies
Professor Rosanna Peeling, London School of Hygiene & Tropical Medicine, UK
Professor David Heymann, London School of Hygiene & Tropical Medicine, UK
Dr. Noah Fongwen, London School of Hygiene and Tropical Medicine & Africa CDC, UK
Scott Chiossi, Chatham House, UK
Carlos Gouvea, Latin American Alliance for In Vitro Diagnostic Development (ALADDiV), Brazil
Dr. Sidney Yee, DxD Hub, Association of Southeast Asian Nations (ASEAN), Singapore
Dr. Jaime Montoya, Council for Health Research and Development, Association of Southeast Asian Nations (ASEAN), Philippines
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