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Abstract

REGULATORY ASPECTS OF PHARMACOVIGILANCE ALONG WITH COMPARISION IN UNITED STATES AND EUROPE

Anisha Sharda*, Ruchi Patel, Naishi Patel, Hiral Vyas, Payal Dixit

L.J Institute of Pharmacy, Ahmedabad, Gujarat, India.

ABSTRACT

Pharmacovigilance is studying the safety and effectiveness of drugs and practice to minimize the possible risk associated with the use of drugs. It has developed to the new challenges it faces. With the modernization there is a rapid increase in knowledge as well as safety about the drug and humans. Pharmacovigilance helps to improve public health and safety. There is a need for new global network to share information and intelligence about benefit and risk of medicinal products. Regulatory aspects of Pharmacovigilance become more specific and advanced. Different Countries follow their guidelines based on specifications.

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