The Paul Ehrlich Institute of Germany has visited the Pharmacy Board of Sierra Leone and help conduct some activities of the the Agency while promising to work others in the coming year.
Explaining the background of what the visitors do, the Head of Pharmacovigilance Department at PBSL, Dr Oneme Abiri explained that The team comprising of Dr. Victoria Olaiya and Dr. Elaine Dibloni/Oubda work on RegTrain-VaccTrain which is a project of the GHPP established by the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) to assist partner countries and the WHO in epidemic prevention measures. In its pilot project, so named VaccTrain I, the project focused on capacity development activities in the area of CTO in selected partner countries. The approach adopted included:
(i) providing technical assistance for the development and implementation of regulatory structures/documents
(ii) enhancing the human resource capacity for Pharmacovigilance and CTO through African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD)’s-instituted Regional Center of Regulatory Excellence training framework like that by FDA Ghana
(iii) supporting regional and pan-African harmonization initiatives through technical support to the African Vaccine Regulatory Forum (AVAREF).
He further explained that their work of assisting in the building of a technical architecture for CTO began in June 2018 by utilizing VaccTrain-validated data originally generated from self-benchmarking results of partner NRAs using the WHO GBT, which provides an objective and well-tested methodology for benchmarking regulatory systems.
Explaining the activities that the visitors helped them to achieve, Dr Abiri said they reviewed the pharmacovigilance guidelines and SOPs including
Pharmacovigilance inspection guideline, Risk management plan guideline and Relevant PV SOPs.
“Plans for 2025 include
Development of the Regulatory Information Management System (RIMS), technical support for advanced training in pharmacovigilance and clinical trials, and placement at WHO-listed authorities” he explained.
The next action of the team was a discussion with top management to plan for the work to be implemented in 2025.
By: PBSL Communications
