SIAPS was asked in 2013 to review the information system and related technical assistance needs of the Mozambican PD for product registration, licensing and inspection, pharmacovigilance, and quality assurance. In addition, a system analysis was performed to define data elements and identify an appropriate tool that is compatible with local technology and capacity. Based on the needs of the Mozambican PD, Pharmadex was chosen as the most appropriate electronic tool for the management of Mozambique’s regulatory systems information.
The goal of the training was to implement Pharmadex in the PD with the aim of ensuring that the department had the necessary skills, knowledge, and technical support to effectively use and sustain it. Implementation involved adapting the tool to agreed-upon data elements, procuring the required hardware and/or software, identifying in-country IT support and maintenance, installing the program(s), finalizing the software, training users, and preparing for launch of the system.