Impressed by the ongoing efforts of the Indian Pharmacopoeia Commission (IPC) in effectively monitoring and implementing the Pharmacovigilance Programme of India (PvPI), the World Health Organisation's (WHO's) Uppsala Monitoring Centre (UMC) has decided to further extend its collaboration by strengthening training and education programme with IPC. This move comes in the wake of India becoming the first country in reporting over one lakh Individual Case Safety Reports (ICSRs) in VigiFlow.

 

The information on this strategic development was informed by Dr Marie Lindquist, director, UMC, Sweden and Christer Backman, medical products agency, Sweden during their recent visit to IPC, wherein they expressed UMCs interest in collaborating with IPC pharmacovigilance activities. As a part of this exercise, UMC which is WHO's collaborating centre for international drug monitoring, will be sending a team of experts on December 8 to IPC, which acts as the National Coordinating Centre (NCC) for PvPI to exclusively train and educate officials from the IPC on signal detection essential for effective Adverse Drug Reactions (ADR's) reporting.

 

Signal detection in pharmacovigilance comprises of selection of drug adverse reaction, preliminary assessment of available evidence and a follow up go how the signal develops. Most pharmacovigilance programmes are focussed on the handling individual adverse event reports also known as ICSRs with less attention paid to systematic analysis and review of aggregate adverse event data and risk management planning. Since individual adverse event case handling remains highly regulated and timely reporting of ICSRs to regulatory authorities and other stakeholders continues to be an important compliance matter, training and educational assistance like this can play a vital role in strengthening the PvPI programme. 

 

 

SOURCE-  http://pharmabiz.com/ArticleDetails.aspx?aid=85374&sid=1