Work package 1
Project management and consortium coordination
| Leader: | Karolinska Institutet (Professor Eleni Aklillu) |
| Objectives: | To provide efficient day-to-day management of the project, exchange of information and collaboration between partners to ensure proper implementation of the work plan and achievement of the PROFORMA objectives and ensuring on-time delivery of scientific and financial reports. |
Work package 2
Baseline survey of the pharmacovigilance situation in Ethiopia, Kenya, Tanzania and Rwanda
| Leader: | Karolinska Institutet (Sten Olsson) |
| Objectives: | Using harmonized pharmacovigilance tools and indicators An in-depth analysis of the presence and availability of basic infrastructure for pharmacovigilance, including relevant background and environmental factors determining its future success will be carried out to identify the missing pharmacovigilance structural elements systems, strength, deficiencies, and gaps. |
Work package 3
Strengthening national pharmacovigilance systems in Ethiopia, Kenya, Tanzania and Rwanda
| Leader: | Pharmacy and Poisons Board, Kenya (Christabel Khaemba) |
| Objectives: | Based on the identified gaps identified from WP2, comprehensive interventional measures aligned with the local needs and priorities will be introduced in each country. |
Work package 4
Post marketing surveillance of medicines and vaccines deployed by Public Health Programmes in mass administration campaigns
| Leader: | Tanzania Food and Drugs Authority (TFDA), (Kissa Mbwana) |
| Objectives: | To establish pharmacovigilance in clinical trials regulation and post-marketing surveillance in public health programmes involving mass drug administration and immunization programmes in Ethiopia, Kenya, Tanzania, Rwanda. |
Work package 5
Short and long-term training in Pharmacovigilance in East Africa
| Leader: | Short -term training (Lareb) MSc training (University of Nirobi) PhD training (Karolinska Institutet) |
| Objectives: | To generate a cohort of pharmacovigilance trained human resources from all stockholders including patients, healthcare providers, regulatory staffs that are engaged in pharmacovigilance data collection, analysis, interpretation and data sharing. |
Work package 6
Communication Dissemination and networking
| Leader: | Karolinska Institutet (Eleni Aklillu) |
| Objectives: | To communicate and disseminate project information and results to a number of key stakeholders including researchers, patients, health care providers, community members, international organizations and policy- and decision-makers. |