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The COVID-19 pandemic took the world by storm and the only way to navigate its associated challenges was to find innovative ways of doing things. Virtual meetings supplanted traditional face-to-face meetings and paved the way for ever-increasing participation, since transportation and logistical obstacles were no longer impediments.

The EDCTP work package 4 which involves a 45-day regulatory attachment of two (2) RCORE trainers at Paul-Ehrlich-Institut (PEI) has this time around decided to take advantage of the virtual space to allow for the participation of more trainers/regulators. PEI (work package lead) with support from FDA Ghana has divided the package into two:

  • 2 weeks virtual training in the form of lectures and seminars

  • 30 days of hands-on activities at the different departments of PEI for two (2) regulators

The main objectives of this package are:

  1. To enhance regulatory skills and knowledge in the area of Clinical Trial Applications assessment and monitoring benefit-risk balance of vaccines and biologics.

  2. To provide mentorship and continuing professional development for regulators involved in the evaluation of Clinical Trial Applications.

The first part of the package which is the two (2) weeks virtual training begins on Monday, June 20, 2022 and ends on Friday, July 1, 2022. This training involves RCORE trainers as well as regulators from Ghana, Sierra Leonne, The Gambia, and Liberia.

The activities lined up for the 2 weeks are in the attached document:

Agenda_Training for FDA Ghana RCORE Trainers_GMT
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