Work Package Four (WP4) The FDA has had several years of experience in monitoring the safety of medicines, vaccines and other health products. The Authority has effectively coordinated the introduction of new vaccines including the pneumococcal/rotavirus vaccines, measles rubella and the ongoing Malaria Vaccine Pilot Implementation Programme, which has gone on for close to two years without major safety concerns.
The FDA is also a Regional Centre of Regulatory Excellence (RCORE). Its Safety Monitoring Department serves as a training centre for regulators from other African Countries.
The broad objectives of WP4 are:
To identify at the health system and community level, implementation challenges in deploying a mobile App for adverse event reporting by patients and healthcare professionals
To design and implement with key stakeholders the best strategies to ensure the Mobile App is more robust, efficient and user friendly for patient and healthcare professional reporting of adverse events.
To assess the impact of the new strategies on reporting of adverse events.