Indian Society for Clinical Research (ISCR) is all set to organise a two-day workshop on pharmacovigilance in Mumbai from October 18, 2008. The proposed workshop would be held at Hotel Mirage, Andheri.

This two-day workshop on pharmacovigilance is expected to impart knowledge on guiding principles, applications and methodology involved in monitoring safety during clinical research and post approval space through interactive discussions, problem solving and sharing issues. Also, the workshop would look for possible solutions, while featuring case studies, hand on training on pharmacovigilance tools such as form designing and filling exercises.

"While safety and well-being of the subjects being the key issue and most critical for the success of any clinical research project, no one in the pharma industry can take patient's safety casually, particularly in post Vioxx scenario. In order to ensure local and international regulatory compliance, besides taking care of patients' well-being, it is necessary to understand the issues involved in 'safety surveillance' during drug development and post approval phase. With the implementation of new Schedule Y, reporting of safety issues to the licensing authority has been made mandatory in India as well. All this calls for in-depth hands on training in pharmacovigilance," said the organisers.

Medical advisors/medical managers, pharmacovigilance/ safety officers, data management personnel, monitors/ CRAs, study managers/team leaders regulatory personnel, quality assurance personnel and data management personnel are expected to participate in this two-day conference.