Proforma

To strengthen the national pharmacovigilance infrastructure and post-marketing surveillance system involving mass drug administration and immunization programmes being deployed under public health programs in selected East African countries (Ethiopia, Kenya, Tanzania, and Rwanda).

Specific objectives

•  Assess the current pharmacovigilance policies, regulations, and infrastructures (in Ethiopia, Tanzania, Rwanda and Kenya) to identify gaps, needs and local priorities using harmonized Pharmacovigilance Indicators tools.
• To introduce comprehensive intervention programs and Good Pharmacovigilance Practices to establish/support pharmacovigilance capacity building tailored for each country based on identified gaps, local priorities and needs.
• To generate a cohort of pharmacovigilance trained staff working in the national regulatory authorities and Medical Universities who can lead and manage a sustainable national pharmacovigilance and regulatory process and training programs.
• To provide Interregional training of trainers’ course on pharmacovigilance and cohort event monitoring for patients, ADR collection and reporting, signal detection on mass drug administration (MDA) and immunization programs being conducted in East Africa.
•  To provide support for staff from regulatory agencies and higher education institutions to attend training and workshops in pharmacovigilance locally and internationally. For sustainability, a total of 12 postgraduates (PhD/MSc) in Pharmacovigilance and pharmacoepidemiology will be trained and assist local medical Universities to initiate postgraduate programme in PV.