The section of apharmaceutical company that is used to fulfill legal tasks and responsibilitiesin relation to pharmacovigilance is designed to monitor the safety profile ofall drugs and medicinal products and detect any change in the balance of theirrisks and benefits is called a pharmacovigilance system.
Similar to any othersystem, this system, too, is characterized by its processes, structures, andoutcomes. For the sole purpose of good pharmacovigilance practices that provideguidelines on the pharmacovigilance system’s structures and processes, thequality of this system can be defined by the characterized system that producesrelevant outcomes based on the pharmacovigilance objectives.
In general, the degreeto which it can be measured is termed quality. This is compared with thepre-determined quality requirements. The quality system is a major part of thepharmacovigilance system and is characterized by its own structures and processes.The quality structure covers the organizational structure, responsibilities,processes, procedures, and resources of the pharmacovigilance system along withresource management. All this requires the personnel to undergo pharmacovigilance training through a large number of pharmacovigilancecourses. The quality shall be asses based on the quality planning, whichincludes planning integrated and consistent processes, the quality of adherencewhich includes carrying out the tasks in accordance with the pre-requisites. Itis also based on quality improvements and quality control and assurance, whichinclude correcting and improving the processes and structures and effectivemonitoring and evaluation of the established processes.
The overall objectivesfor pharmacovigilance include:
- Adhering to all the legal requirements for the vigilance tasks and responsibilities.
- Contributing to public health.
- Promoting the effective as well as safe use of medicinal products.
- Preventing the adverse reactions caused by these medications or drugs.
In order to fulfillthese objectives, good pharmacovigilance training guidelines must be adhered to at all times. These guidelineshelp in designing the optimum structures and processes in order to achievethese objectives.
