At a time when the Indian pharma industries are coming under increased scrutiny by US regulators for lapses in quality and the government of India citing delayed regulatory approvals as a primary concern, TAKE Solutions, a globally recognised knowledge intensive technology player, has launched PVIndia, a pharmacovigilance peer network, to mutually discuss and ideate on solutions for pharmacovigilance challenges faced by them after the launch of their products overseas.
PVIndia will be organised and managed by TAKE Solutions' life sciences division, Navitas.
PVIndia, an exclusive membership based network of emerging global pharma companies from India, will provide a bi-annual neutral forum for heads of safety and pharmacovigilance leadership of global pharma companies to debate the latest subjects of interest and collaboratively generate insights on regulatory issues. Besides providing complimentary membership and access to pvtech for pharmacovigilance heads of information technology, the platform will provide peer-to-peer comparison of pharmacovigilance productivity data to set new standard for pharmacovigilance system in India.
The topics which will be covered by PVIndia forum include latest regulatory insights globally, how to ensure pharmacovigilance inspection readiness, moving beyond compliance, and discussion on the future needs of the forum.
Furthermore, with the membership of 102 and 300+ global safety leaders participating in a year, the networks aids in exploring the value of Indian pharmacovigilance system in the global market.
The network is aimed at providing a forum for the pharmaceutical industry to discuss and come up with solutions for challenges faced by them in the export market.
“We are spearheading this first-of-its kind network in India. Whilst we believe that drug safety can be a source of competitive advantage, we see greater mutual benefit in the sharing of experience. Through our pharmacovigilance networks; pvnet, pvconnect, pvtech, and pvindia, we intend to shape the future of pharmacovigilance,” said Ram Yeleswarapu, president & CEO, TAKE Solutions.
Yeleswarapu said “The global regulatory landscape is changing, compliance is getting tougher. Pharmacovigilance is a critical hurdle to launch success. PVIndia provides safety heads of member pharmaceuticals with a forum to discuss regulatory challenges, observations and status of EMA, FDA. It also enables them to ensure pharmacovigilance inspection readiness, pharmacovigilance quality management system, audits. The members can access the inspection findings, best practices for case handling, aggregate reporting, benefit risk management.”