Good Pharmacovigilance Practise

1
Good Pharmacovigilance Practice Guidelines 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
systems 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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• Good Pharmacovigilance Practice Guidelines
• Good pharmacovigilance practice guidelines
• The good pharmacovigilance practice guidelines
  include
• All criteria based on patients, healthcare
  professionals, and public health on the sole
  aspect of safety have to be met.
• All the organization members should be involved
  in support of the vigilance system based on the
  task of ownership and responsibility for the most
  optimal level of quality in accordance with
  their individual responsibilities.
• The higher management levels should have good
  leadership qualities and must be capable of
  driving the team toward achieving the
  above-formulated objectives.
• All members of the team must strive toward
  improving the quality cycle of the drug.
• The resources and tasks should be structured such
  that the processes are proactive, continuous,
  integrated, risk-proportionate, and co-operative
  conduct of pharmacovigilance training
• An overall highly efficient and co-operative
  rapport should be maintained by all departments
  related to the pharmacovigilance department.
  Especially with the marketing department,
  co-operation should be at the peak.
• Good relations and co-operation should also be
  fostered with the respective authorities and
  public health organizations in accordance with
  applicable legal provisions.
• The need for pharmacovigilance is entirely based
  on the safety profile of the drugs and medicinal
  products that are consumed by the patients. With
  todays rapidly growing technology, medicine is
  also advancing. The new chronic illnesses need a
  suitable cure with high bounds of safety. This
  is making the pharmacovigilance process more
  important now than ever. Thus, for a better a
  good pharmacovigilance department, the above
  guidelines have to be adhered to. The main
  reasons to adhere to these guidelines include
• Emerging safety issues related to the balance of
  risks and benefits of the drugs and medicinal
  product.

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• Good Pharmacovigilance Practice Guidelines
• New and unknown information that arrives from the
  specific marketing authorization holders.
• Procedures relevant to pharmacovigilance may give
  rise to new information resulting in the
  updating of the process by itself.
• On-going or new clinical trials may give rise to
  new symptoms or adverse effects of the drugs,
  causing the process to need updating frequently.
• The leaders and higher authorities in the
  pharmaceutical world have a great deal to
  consider when considering good pharmacovigilance
  training. The risk versus benefit ratio parameter
  of any drug or medicinal therapy is one of their
  lists top contenders. Thus the scope of good
  pharmacovigilance practices includes interaction
  with the medication or drug, abuse and misuse of
  the drug or medication, medical errors, lack of
  efficacy, adverse reactions, and good
  co-operation.