Overview of the newly introduced Lebanese guidelines on good pharmacovigilance practices

Abstract

The practicum report, “Overview of the Newly Introduced Lebanese Guidelines on Good Pharmacovigilance Practices”, goes through the new guidelines established by the Lebanese Ministry of Public Health (MoPH) on pharmacovigilance (PV). The practicum, conducted at Mersaco, focused mainly on understanding, reviewing, and preparing presentations for the eight modules of the guidelines in a simplified manner. The internship duties involved going through and comprehending all eight modules, followed by preparing informative presentations, for each module. Moreover, the internship entailed managing Individual Case Safety Reports and medical inquiries along with conducting systematic reviews of literature for adverse events, all while ensuring thorough documentation and compliance with regulatory requirements. Another aspect of the internship included performing a self-assessment/audit on certain PV activities. The report also provides a summary of each module. In addition, several recommendations are proposed to find better ways to implement and operate in terms of PV on both organizational and public health levels. The tasks that were carried out, lasting around 320 hours, have offered crucial knowledge on the functioning of PV systems. This experience has been beneficial for the intern’s development both professionally and personally, in the field of public health.