Various Aspects Of Pharmacovigilance

Pharmacovigilance is defined as the science of monitoring

, collecting, assessing, researching and evaluating the information that is procured from patients and healthcare providers concerning biological products, traditional and herbal medicines and conventional medicines. People in Pharmacovigilance physician jobs are assigned the responsibility to do so in order to:

Prevent the damage that is done to patients

Identify the potential new hazards and other information concerning the drugs

The task is carried out in compliance to the rules and regulations set by the MHRA Pharmacovigilance Inspectorate which is an important segment of the Inspections and Standards Division of the Medicines and Healthcare products Regulatory Agency (MHRA). It is in charge of checking the fact that the pharmaceutical companies comply with regulations set by the EU and UK legislation concerning the supervision and monitoring of the drugs that are administered to the patients.

There are three types of inspections that are carried out as part of the regulatory process. These include:

Routine national inspections: As the name suggests, these are regular and routine inspections that are carried out by MAHs or the market authorisation holders in UK on a regular basis. They are informed about the inspections well in advance. These inspections are increasingly system based, implying that the inspectors are focussed on examining the procedures and the systems that are used by the market authorisation holders to follow the national rules and regulations governing Pharmacovigilance.

CHMP Requested Inspections: The CHMP or the Committee on Human Medicinal Products may make a request for an inspection in connection to particular centrally authorised products. This can be a regular scheduled inspection or one triggered by an incident. The process revolving around CHMP requested Pharmacovigilance reviews are described in detail in Volume 9A, Part 1 of the regulatory laws.

National Inspections for a cause: These can also be referred to as ad-hoc inspections that are necessitated as a result of a number of reasons. These include suspected infringement of the legislation pertaining to the supervision of the safety of medicinal products and safety issues in general. These may also be triggered as a result of the referrals made by the Member States. The market authorisation holders are always informed in advance about the inspections with exceptions occurring in a few cases.

There are situations in which even sites that are located outside UK are subject to regulatory inspection. This is true in case of medicines that are promoted in the European Union or UK. Professionals for these jobs are recruited from amongst experts and regulatory consultancies have an important role to play in outlining the requisite profile for a candidate.

The inspection findings are graded and the inadequacies detected in the system are graded in three different ways. These include Major, Critical and Other defects. These defects in the Pharmacovigilance systems, processes and practices can have an adverse effect on the safety, rights and overall health of the patients and may even turn out to be risky for public health and is violation of the guidelines and legislation.

by: Steven Hayes

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