The overall objectives for pharmacovigilance include
The section of a pharmaceutical company that is used to fulfill legal tasks and responsibilities in relation to pharmacovigilance is designed to monitor the safety profile of all drugs and medicinal products and detect any change in the balance of their risks and benefits is called a pharmacovigilance system.
Similar to any other
system, this system, too, is characterized by its processes, structures, and
outcomes. For the sole purpose of good pharmacovigilance practices that provide
guidelines on the pharmacovigilance system’s structures and processes, the
quality of this system can be defined by the characterized system that produces
relevant outcomes based on the pharmacovigilance objectives.
In general, the degree
to which it can be measured is termed quality. This is compared with the
pre-determined quality requirements. The quality system is a major part of the
pharmacovigilance 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 with
resource management. All this requires the personnel to undergo pharmacovigilance
training through a large number of pharmacovigilance
courses. The quality shall be asses based on the quality planning, which
includes planning integrated and consistent processes, the quality of adherence
which includes carrying out the tasks in accordance with the pre-requisites. It
is also based on quality improvements and quality control and assurance, which
include correcting and improving the processes and structures and effective
monitoring and evaluation of the established processes.
The overall objectives
for 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 fulfill
these objectives, good pharmacovigilance
training guidelines must be adhered to at all times. These guidelines
help in designing the optimum structures and processes in order to achieve
these objectives.
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