By Esther Wright
The Paul Ehrlich Institute (PEI) of Germany recently visited the Pharmacy Board of Sierra Leone (PBSL), offering assistance in various activities while outlining plans for further collaboration in the coming year.
Dr. Oneme Abiri, the Head of Pharmacovigilance at Pharmacy Board of Sierra Leone (PBSL), provided an overview of the Paul Ehrlich Institute (PEI ) team’s mission. The delegation, led by Dr. Victoria Olaiya and Dr. Elaine Dibloni/Oubda, is involved in the RegTrain-VaccTrain Project. This initiative is part of the German Federal Ministry of Health’s (BMG) GHPP, aimed at supporting partner countries and the World Health Organization (WHO) in epidemic prevention efforts. The project’s pilot phase, VaccTrain I, focuses on building capacity in Clinical Trials Operations (CTO) in selected partner countries.
Key activities of the project include:
- Offering technical assistance to develop and implement regulatory frameworks and documents.
- Strengthening human resource capacity in Pharmacovigilance and CTO through the African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) framework, which includes training programs like those at the FDA Ghana.
- Providing technical support for regional and pan-African regulatory harmonization, particularly with the African Vaccine Regulatory Forum (AVAREF).
Dr. Oneme Abiri further explained that the PEI’s efforts in establishing a technical framework for CTO began in June 2018, leveraging VaccTrain-validated data generated from the self-benchmarking results of partner National Regulatory Authorities (NRAs), using the WHO’s Global Benchmarking Tool (GBT). This method offers a reliable approach to assess and improve regulatory systems.
During the visit, the team assisted PBSL in reviewing its Pharmacovigilance guidelines and Standard Operating Procedures (SOPs). This included an in-depth review of the Pharmacovigilance Inspection Guideline, Risk Management Plan Guideline and other relevant PV SOPs.
Looking ahead, Dr. Oneme Abiri shared plans for 2025, which include the development of a Regulatory Information Management System (RIMS), advanced training in Pharmacovigilance and clinical trials, and further collaboration with WHO-listed authorities.
The visit concluded with a discussion between the PEI team and PBSL’s top management, outlining key activities and goals for the upcoming year.
