Work Package Four (WP4) - Patient Safety and Pharmacovigilance

This work package will be led by the Ghana Food and Drugs Authority (FDA), the agency responsible for receiving adverse events reports from patients and care providers. For SAVING, this work package will conduct IR around the deployment of a mobile application for patient reporting of adverse events being deployed with the pilot roll out of the new malaria vaccine. The IR will allow the FDA to learn valuable lessons for the adaptation of the mobile application to suit the Ghanaian context.

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.

Lead Organisation
Work Packages


Team Members

Seth Seaneke

Food and Drugs Authority, WP4 Lead


George Sabblah

Technical Coordinator

Adela Ashie


Abena Asamoa-Amoakohene


Rhoda Appiah

Communications and Reporting

Serah Armah

Finance Officer

Jeremiah Ewudzie-Sampson

Data Management Representative

Dr. Desmond Klu

UHAS Researcher/Embedded Scientist