Pharmacovigilance is a scientific discipline which mainly pertains with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, devices or biologics in order to increase their safety. The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic Pharmacovigilance framework. The adverse event data generated by clinical trials worldwide is enormous and has led to the outsourcing of the Pharmacovigilance and Pharmacoepidemilogy services of the Pharma-Biotech Research and Development. This fact is compounded by the increasing number of local clinical trials has led to a spurt in the Pharmacovigilance job market in India.
The Pharmaceutical industry in India is valued at Rs. 90,000 crore and is growing at the rate of 12 – 14 % per annum. India is rapidly emerging as a hub of Global Clinical trials and a destination for Drug Discovery and Development along with for Pharmacovigilance.
New Chemical Entities (NCE), high tech Pharma products, vaccines as well as new dosage forms are being introduced in the country which throws up the challenge of monitoring Adverse Drug Reactions (ADRs) over a large population base. Pharmacovigilance focuses on adverse events, which is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems [WHO, 2002]. Consequently, the demand for qualified Pharmacovigilance and clinical research specialists has grown significantly with supply at present, not being able to match demand. With the advent of more pharmaceutical companies looking at India for their Pharmacovigilance activities, there is an imminent need to develop good professionals in Pharmacovigilance and there is ardent need of trained professionals in Pharmacovigilance.
As Pharmacovigilance and Clinical Research are becoming an important part of drug development as it deals with the patient’s safety keeping this in mind IBRI NOIDA has introduced certificate course in Pharmacovigilance.
||Certificate Program in Pharmacovigilance
||Comprehensive Program in Clinical Trials Data Management and Pharmacovigilance
||Course Structure:For Above Courses
||Exam Fees For 6M ,12M