Regulatory preparedness to authorize the use of pandemic vaccines in importing countries

WHOA

Early-release course

You are accessing an early-release version of the regulatory preparedness to authorize the use of pandemic vaccines in importing countries course, produced by the WHO Academy. We encourage you to provide feedback on your learning experience. We will use your feedback to adapt and improve the course and the WHO Academy online platform.

About this course

This programme expects to improve national competence in decision-making to authorize the use and deployment of pandemic vaccines to address a public health emergency in a timely and coordinated manner in importing countries.

Who is this course for?

This course is primarily designed for audiences from:

national regulatory authorities (NRAs) of medical product registration,
national disease control authorities handling disease control and public health emergency response,
national immunization programmes in charge of vaccine deployment, and
the WHO Country Office representative in charge of regulatory systems strengthening (RSS) and/or public health emergency response.

What will you learn?

In this course, learning activities and lessons focus on what you, the regulatory professionals, do. Each module offers opportunities to practise the core competencies required to make timely, effective decisions during a public health emergency, without compromising quality, through multiple choice questions, exploratory tasks, reflection, self-assessment and case studies. The interactive tasks incorporate pre-recorded videos, audio narration, readings and guides.

Assessment and award

A WHO Academy Award of Completion is awarded for successful completion of all learning activities for each of the four modules.

Learning experience

This is a learner-centred, competency-orientated online course delivered in four self-paced modules:

Module 1. General considerations
Module 2. Regulatory evaluation processes
Module 3. Good regulatory practice, good reliance practice, risk assessment
Module 4. Vaccine composition, quality control, safety and deployment
Module 5. Simulation

It is estimated each of the four online modules will take about 75–90 minutes to complete. The modules are to be completed in consecutive order: module 1, module 2, module 3 and module 4. An interactive, online simulation exercise is available at the end of the course (2024 release).

After successful online programme completion candidates may register for a three-day, in-person regulatory systems strengthening (RSS) workshop. The live workshop supplements, but is not part of, the WHO Academy online programme. The workshop is run by the WHO RSS unit and locations differ among the WHO regions. The workshop includes a live pandemic simulation exercise in which participants join forces to overcome authentic logistical, legal and organizational challenges to vaccinate their population as quickly and safely as possible.