Project: Developing LMHRA capacity to effectively exercise its regulatory mandate in clinical trials and health research in Liberia
Acronym | Lib-Regul-Trials (Reference Number: EDCTP-Ethics2015-868) |
Duration | 01/02/2017 - 31/01/2019 |
Project Topic | The Liberia Medicines and Health Products Regulatory Authority (LMHRA) through a well-attended, restricted and participatory stakeholders’ meeting, discussed and agreed on the acceptable regulatory framework design, pathway and implementation plan. This meeting constituted the technical working group (TWG) comprising members from various participating health institutions. An external consultant was hired to provide technical support to the technical working group to develop the regulatory pathway documents (regulations, guidelines and SOPs). The terms of reference was also developed for the TWG to ensure the efficiency and effectiveness in their roles and responsibilities. The TWG with technical support from the consultant, developed the regulatory framework, regulations, guidelines, standard operating procedures (SOPs) and monitoring checklist for clinical trials. The adoption of these documents is still pending as they have been submitted to the management of LMHRA which will then organize a stakeholder’s meeting. The personnel and institutional capacity of LMHRA is being developed and strengthened through the acquisition of requisite training, needed logistics (a vehicle), the establishment of pharmacovigilance institutional and contact persons, and the effective participation in regional harmonization meetings. This effective collaborative effort of participation in regional harmonization meetings is further improving LMHRA regional collaboration and effective information dissemination. |
Network | EDCTP2 |
Call | Ethics and Regulatory capacities 2015 |
Project partner
Number | Name | Role | Country |
---|---|---|---|
1 | Liberia Medicines and Health Products Regulatory Authority | Coordinator | Liberia, Republic of |