With
the globalization of the pharmaceutical industry, increased use of
medicines and public awareness of safety issues have come forth with
the challenges in four areas of operations—organizational alignment,
operations management, data management, and risk management. .
India is
the fourth largest producer of pharmaceuticals in the world and there
is a surfeit of drug brands-more than 6,000 licensed drug manufacturers
and over 60,000 branded formulations emerging as a preferred hub for
clinical trials. Thus
in today’s biopharmaceutical product landscape, companies must be aware
of crucial safety information about their products. Pharmacovigilance
is particularly important in the first few years after launch, when
knowledge of the safety profile is expanding based on exposure to a
much wider range of patients than is possible during clinical trials.
i3 Drug Safety is uniquely positioned to provide comprehensive
pharmacovigilance services.
Pharmacovigilance in India is gaining momentum within the arena of
Research and Development. India has emerged as a preferred destination
for outsourcing clinical trials. With the increasing clinical research
and development by the Indian Pharmaceutical companies, the need for
Good Pharmacovigilance Practices has increased tremendously over recent
years.
As Pharmacovigilance is becoming an
important part of drug development as it deals with the patients’
safety. Keeping this in mind, Bioinformatics Institute of India has
designed a Certificate Course on Pharmacovigilance.
"This program will increase the knowledge and importance of amongst clinical research professional, which eventually would help in increasing the quality of clinical trials in India".
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