The 6 th PROFORMA consortium annual meeting was held on the first week of February in Addis Ababa.
The project aims to strengthen the national pharmacovigilance infrastructure, post-marketing surveillance system and clinical trial regulatory capacity in Ethiopia, Kenya, Tanzania and Rwanda.
The Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for Medicine regulatory and harmonization in Africa (PROFORMA) project was launched in April 2018. The Consortium constitutes five medical universities and four national medicine regulatory authorities including Addis Ababa University, Karolinska Institute, Muhimbili University of health and applied Sciences, University of Rwanda, and university of Nairobi, the Ethiopian Food and Drugs Authority (FDA),
Tanzania Medicines and Medical devices Authority, Pharmacy and Poisons Board, Kenya, Rwanda Food and Drugs Authority, and Netherlands pharmacovigilance Centre, Lareb.
The project aims to establish collaboration between National Medicine Regulatory Authorities, public health programs and medical universities to work together to monitor medicine safety and ensure suitability of the pharmacovigilance capacity in the four countries.
In his keynote address, Professor Tassew W/Hanna, AAU President through his representative said, the past three years have been one of the most challenging periods in our recent history. Covid-19 was a particular threat to Africa because of the almost complete import dependence for essential medicines,
including vaccines and diagnostics. The capacity to ensure safety of these imported products, and in the near future, products manufactured within country is paramount. The university has dedicated CDT-Africa to this particular task.
The role of academic institutions is significant to ensure the sustainability of the pharmacovigilance capacity built. Through the project AAU has engaged in creating a critical mass of pharmacovigilance-trained staff supporting the EFDA to ensure safety of the medicines and vaccines used by the public.
Ms. Heran Gerba, EFDA Director said that pharmacovigilance mainly aims at improving patient care and safety in relation to the use of medicines and all medical and paramedical interventions. It also improves public health and safety by contributing in the assessment of benefit, harm, effectiveness and risk of medicines.
The provision and distribution of quality and safe medicines and vaccines play an important role in accessing health services to our population. Assuring the safety of medicines and vaccines used in our health care systems requires a well-established pharmacovigilance system. Consortiums like PROFORMA are very critical for establishing a base in establishing a sustainable pharmacovigilance system by allowing sharing of experiences and pool of expertise in pharmacovigilance.
Professor Eleni Aklilu, PROFORMA Project Coordinator presented key activities carried out through the project in 1. Baseline assessment of pharmacovigilance systems to identify gaps for intervention 2.Active Safety surveillance to establish the safety of treatment regimens used in Preventive Chemotherapy 3. Vaccine active safety surveillance 4. Pharmacovigilance capacity building.
Through the project 12 postgraduate students (7 PhDs + 5 MSc) are trained, and several training of trainers were conducted. More than 20 people attended the hybrid meeting which was held for five consecutive days.