Good Pharmacovigilance Practice Guidelines
This system, like all other systems, is defined by its processes, structures, and outcomes. The quality of this system can be defined by the characterized system that produces significant parameters based on the drug safety objectives for the sole purpose of good pharmacovigilance practices that provide guidelines on the pharmacovigilance system's processes and structures.
The quality
structure includes the pharmacovigilance system's organisational structure,
responsibilities, processes, procedures, and resources, along with resource
management. All of this necessitates the completion of pharmacovigilance and
clinical research training.
Good Pharmacovigilance
practice guidelines include:
- All criteria based on
patients, healthcare professionals, and public health must be met solely on the
basis of safety.
- All departments
associated with the pharmacovigilance department should maintain an overall
highly efficient and cooperative rapport.
- All members of the
organisation should be involved in the support of the vigilance system based on
the task of ownership and responsibility for the highest quality standards in
accordance with their individual responsibilities.
- In accordance with
applicable legal provisions, good relations and cooperation should also be
stimulated with the respective authorities and public health organisations.
- All members of the team
must work together to enhance the drug's durability cycle.
Thus, in order
to improve the pharmacovigilance department, the above guidelines must be
followed. The following are the primary reasons for complying with these
guidelines:
- Emerging safety
concerns associated with the drug and medicinal product's risk-benefit
ratio.
- Pharmacovigilance
practices may generate new information, requiring the process to be updated on
its own.
- Current or new clinical
trials may result in new symptoms or drug side effects, possibly requiring
upgrades to the process.
Thus, the need
for pharmacovigilance is solely determined by the safety profile of the drugs
and medicinal products that patients consume.
As a result,
interaction with the medication or drug, abuse and misuse of the medication or
drug, medical errors, lack of efficacy, adverse reactions, and good co-operation
are all covered by good pharmacovigilance practices.
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