Pharmacovigilance: An emerging area of ​​studying the adverse effects of drugs
Pharmacovigilance (Pv) became increasingly important after the occurrence of many serious disasters with adverse drug reactions (ADRs), including the thalidomide tragedy in Germany in the early 1960s. Industry-compliant regulators have formulated strategies for dealing with ADRs worldwide.

What is pharmacovigilance?

It deals with drug safety and is defined as the study and prevention of side effects caused by pharmaceutical products. In response to the thalidomide disaster, the WHO set up the International Drug Monitoring Program. More than 134 countries have joined and supported the WHO Primary Program. “Governments around the world support and assist in the implementation of pharmacovigilance courses, as their main objective is to ensure that medical students are informed about the adverse effects of certain drugs,” said Madhu Chitkara, Pro-Chancellor of Chitkara University in Punjab.

Increasing relevance

With the global rise in lifestyle diseases, drug consumption has increased along with increased adverse drug reactions (ADRs) and drug toxicity. In addition to a sudden surge in strict nationwide compliance practices around the world, the current global pandemic has also spurred global drug development and pharmacovigilance practices. Pharmacovigilance aims to improve patient care and the safety of using drugs. Supporting public health programs by providing reliable, balanced information for the practical assessment of the benefit-risk profile of medicines.

Course content

The pharmacovigilance graduate program typically covers topics such as hands-on training on ICSR processing, quality management, overall reporting, and compliance management.

“The main focus is on improving expertise in drug evaluation. The program aims to provide intense technical exposure related to clinical research and potential drug safety, with specializations in ICSR processing / quality management / medical safety writing and compliance management, ”she says.

As pharmacovigilance is an ever emerging field, the trend and need for industry-oriented courses is increasing. The program includes a six-month internship at clinical research institutions (CROs).

The industry leading program offers specializations such as Advanced ICSR Processing, PV Quality Management, Writing PV Medical Safety, and PV Compliance Management.

Eligibility criteria

Students who have achieved at least 50% with degrees in science, including medicine and non-medicine, medicine, nursing and biotechnology, are eligible for admission to the MSc program in pharmacovigilance and clinical research at Chitkara University.

Career prospects

The pharmacovigilance industry is expected to grow at an annual rate of 10.6% through 2025, becoming a $ 8.9 billion industry worldwide. Tanveer Naved, director of pharmacology at Amity University, says the demand for pharmacovigilance professionals will increase in the years to come.


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