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. 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
Testing strategies and policy development have now become increasingly complex and for the COVID-19 pandemic, there is limited time to conduct research to inform policy. At the end of the course, learners should be able to:
Describe the value of diagnostics in clinical decision making and disease control for COVID-19 and other diagnostics for diseases of public health importance
Accelerate policy development by collaborating with different stakeholders to assess acceptable risks as a trade-off for incremental patient or societal benefits in the use of diagnostic tests
Participate in a community of practice to share best practices and updates on evidence to inform policy
Click the orange "Enroll For Free" button in the banner at the top of the page for access to the education. An outline of the activities is below.
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Live Webinar: 29 March 2021 @ 12:00 GMT & repeated @ 17:00 GMT • Measurements of diagnostic test performance and effectiveness • Difference between evaluation, validation and verification • Key considerations in assessing clinical performance studies
Live Webinar: 9 April 2021 @ 12:00 GMT & repeated @ 17:00 GMT • Trade-offs between accuracy, accessibility, affordability and time to result • Key considerations in balancing risks and benefits using COVID-19 tests as examples |
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Live Webinar: 31 March 2021 @ 12:00 GMT & repeated @ 17:00 GMT • Measurements of diagnostic test performance and use of predictive values • Difference between evaluation, validation and verification • Key considerations in policy development for diagnostic tests for COVID-19 and other infectious diseases
Live Webinar: 9 April 2021 @ 12:00 GMT & repeated @ 17:00 GMT • Trade-offs between accuracy, accessibility, affordability and time to result • Key considerations in balancing risks and benefits using COVID-19 tests as examples |
 Resources and Reference Materials |
Professor Rosanna Peeling and Professor David Heymann from the London School of Hygiene and Tropical Medicine are Co-directors for the course.
Professor David Heymann, London School of Hygiene and Tropical Medicine, UK
Dr. Ilesh Jani, Director General, National Institutes of Health, Mozambique
Dr. Patricia Garcia, Cayetano University, former Minister of Health, Peru
Dr. Debi Boeras, Global Health Impact Group, USA
Dr. Sidney Yee, Diagnostics Development Hub, Singapore
Dr. Noah Fongwen, London School of Hygiene and Tropical Medicine, UK
Leticia Seixas, Latin America Alliance for Development of IVDs, former head of Medical Device regulation, ANVISA, Brazil
Washington Samukange, former Medicine Controls Council, Zimbabwe, currently Scientific officer, Paul Erlich Institute, Germany
Carlos Gouvea, President of ALADDiV (Latin American Alliance for the Development of In Vitro Diagnostics)
Dr. Joseph D. Tucker, London School of Hygiene and Tropical Medicine, UK; University of North Carolina at Chapel Hill School of Medicine, USA
Provided by learners from this course:
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Regulators Track - Session 1
Regulators Track - Session 2
Policy Makers Track - Session 1
Policy Makers Track - Session 2
