Target Audience

This activity is specifically designed for:

  • Regulators

Learning Objectives

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

Course Directors

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

Learn more!

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