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Importance of Pharmacovigilance and Pharmacoepidemiology

Pharmacovigilance and Pharmacoepidemiology

Importance of Pharmacovigilance and Pharmacoepidemiology

What is Pharmacovigilance?

Pharmacovigilance, also known as drug safety, is one of the most essential functions of pharmaceutical industry and is basically concerned with safety and efficacy of therapeutic drugs, biologicals or devices and deals with surveillance of adverse effects caused thereof. This involves diagnosis, management, and prevention of teratogenic effects caused by the drugs. Thus, it is evident that the basic focus of pharmacovigilance is patient’s safety.
An adverse effect can be defined as any unintended reaction that occurs in a patient’s body due to the administration of the drug. It could sometimes be a life-threatening event that leads to hospitalization, permanent damage or even the death of the patient. Not all side effects can be considered as adverse events since they do not cross the line of drug’s efficacy. Drugs should be continuously monitored for adverse effects and the detected effects, if any, should be reported to health authorities mandatorily on a regular basis.

What is pharmacoepidemiology?

On the other hand, pharmacoepidemiology is a combination of clinical pharmacology and epidemiology. It deals with the study of the use and effects of drugs in large populations across the world during the post-marketing phase. In short, pharmacoepidemiology is nothing but pharmacovigilance that happens in the post marketing surveillance phase. It gives an assessment of uses as well as risks that arise from the use of drugs. Pharmacovigilance and pharmacoepidemiology together play an influential part in minimizing the adverse reactions and ensure the safety and efficacy of drugs.

What is the scope of pharmacovigilance and pharmacoepidemiology?

Currently, pharmacovigilance and pharmacoepidemiology services are mostly outsourced to various multinational companies (CRO/BPO/KPO) owing to enormous data available on adverse drug reactions generated through clinical studies. In addition to this, all health authorities are keen on listing the rare and unknown adverse reactions that result from newly marketed drugs. Almost all pharmaceutical companies are implementing pharmacovigilance reporting systems to monitor the adverse reactions of the products launched by them and report data pertaining to pharmacoepidemiology. This indicates that drug safety professionals have opportunities across various life science companies including biotechnology companies, pharmaceutical companies, CROs, consultancies, generics companies and health authorities.

Online courses in Pharmacovigilance and Pharmacoepidemiology at James Lind Institute

In order to bridge the gap between academia and industry, various training programs on pharmacovigilance and pharmacoepidemiology tailored to cater the needs of employers are made available online. James Lind Institute provides a self-paced Professional Diploma in Pharmacovigilance and Pharmacoepidemiology to train individuals on pharmacovigilance systems, global safety standards, guidelines and regulations related to these branches. The program curriculum has been designed and evaluated by industry experts and is a perfect pick for individuals, both with and without pharmaceutical background, who wish to pursue their career in pharmacovigilance sector.
This course provides an overall knowledge about epidemiology and evidence based medicine, principles of pharmacovigilance, pharmacovigilance and selected system organ classes, pharmacovigilance systems, global pharmacovigilance and safety standards, pharmacovigilance regulations and guidelines and pharmacoepidemiology. The program is suitable for fresh graduates as well as working professionals with a degree in bioscience/life sciences, MBBS, BDS, BPT, BAMS, BHMS, BUMS etc, pharmaceutical sciences, biostatistics, bioinformatics, chemistry, nursing and allied sciences.
Technologically advanced e-campus of JLI acts as a contemporary substitute to standard classroom programs. In addition, they offer personalized classroom activities through an Online Campus Tutoring Centre, mock drills, tutoring and freelancing opportunities.
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