Pharmacovigilance & Clinical Trials

Biography

Biography: Carolle Laure Kpoumie

Abstract

The scientifi c and technical advances and increasing demands in terms of drug safety in the case of pharmacovigilance have undergone major changes since the last decade. Th e work with all partners enabled the draft ing of a regional project to support the implementation of pharmaceutical vigilance. Th is project is implemented by OCEAC as an Agency Execution of CEMAC public health projects with support from WHO, the European Union. To ensure the safety of patients and consumers or drug; but also the desire and the need for European harmonization and the development of countries in the case of Cameroon. Improvement of the system of Good pharmacovigilance practices guideline in this part of the World, is responsible to create a new measurements to improve the vigilance system of drug safety, in the case of pharmacovigilance. Th esharing of information between Europe and developing countries as Cameroon and pathways in our study. To be aware of the Good pharmacovigilance practices guideline, especially, anticipation of the adverse drug reaction and support of the monitoring of the drug (collect, documentation, verbatim, recording and transmission, management of the adverse drug reaction/risk/benefi t ratios, transparency...).Among the various pharmacovigilance activities impacted by the new regulations of case management of pharmacovigilance, the data collection, procedures, investigations, transmission of adverse events to promoters and to the competent authorities. Th e drug safety reports for the post AMM medicines and a balance of ratio benefi ts/risk of the drug. Th e fi nality of this study provides technical expertise to frame, analyze levels of knowledge pharmacovigilance in Cameroon, the Lomie district hospital (East Region of Cameroon). Th is is in order to formulate a hospital, regional, and National project in drug safety or pharmacovigilance; to establish a good pharmacovigilance practices guideline. Th e practice of good pharmacovigilance guideline in the hospital organization local, regional and national in this area is still low. Th e awareness on the knowledge of good pharmacovigilance practices with the new European reglementation relating to adverse drug reaction and risk/benefi t ratio of drugs is not yet applicable. Th is study is a concrete example of implementation in a medical structure in Cameroon. Objectives are verifi cation of level of awareness of medication security, analysis of knowledge on good Pharmacovigilance practices guideline. Th e development of strategy for implementation of good pharmacovigilance practices related to the new European reglementations, in practices related to adverse drug reaction reported by patients. Physician, medical students, medical representative, nurse will be formed, evaluated, by the establishment of the training of health workers, consumers, by specialists in pharmacovigilance. Concerning the assessment, defi nition, data collection, archiving, recording, data processing, communications, investigations of cases, the risk/benefi t ratio, safety of the drug, in coherence and harmonization with new European regulations will be described.