Pharmacovigilance as we know is a science with a set of pre defined functions to collect, analyse, monitor adverse event reports in understanding the safety profile of drug. The set pre defined functions would include case processing through data entry of adverse event forms into safety database, medical review, aggregate reporting, signal detection, risk evaluation and mitigation strategies. With patients awareness and regulatory compliance we may have seen a surge of adverse event data over last few years , resulting in the urgent need for the application of automation. Pharmacovigilance is the only discipline where in which timelines and quality data are evaluated on a benchmark of 100 % and a compromise in these two parameters are considered to be a zero tolerance. Automation of above pre defined function is possible through machine learning, which is an integral components of Artificial Intelligence. What is Artificial Intelligence ?     ...

The International Coalition of Medicines Regulatory Authorities’ (ICMRA) has released a policy paper which examines strengths and limitations of big data and analytics in pharmacovigilance. The working group of the ICMRA comprising of subject matter experts from European Medical Agency (EMA), Health Canada and Medicines and Healthcare Product Regulatory Agency (MHRA) had developed the policy paper with a list of initiatives pertaining to the implementation of big data analytics in pharmacovigilance . ‘Big Data’ is a sub group of ICMRA working group. One of key areas in exploring the opportunities with big data and analytics would be in the spontaneous reporting system (SRS) which currently contains limited structured / unstructured data. Data collected through voluntary reporting, often has its own challenges with limited information available about patient’s demographics, medical history, past drug history, concomitant therapies, onset date and time of adverse event and ...

The Indian pharmacopeia commission (IPC) has developed an android based application for reporting adverse drug reactions. The app under the name PVPI ADR would facilitate auto filling of data with easy attachments of source documents/ image files comprising of laboratory test reports etc. and would generate XML files, facilitating E2B submissions. The app could be easily used by both health care professionals and consumers. Under the ‘Pradhan Mantri Kaushal Vikas Yojana’  a Skill development programme was organized where by , the IPC , National coordinating centre- Pharmacovigilance programme of India (NCC PvPI) under the Union Health Ministry have trained 300 physicians and pharmacist. India is transcending as one of the nations with robust pharmacovigilance and patient safety systems. We at Think I are also driven to produce Pharmacovigilance safety  database solutions using cloud based technology which are not only cost effective and user friendl...

In the recent times we have seen a growing prevalence of diseases and chronic disorders, in order to eradicate life threatening diseases and chronic conditions, we have made one leap forward towards developing an effective pharmacovigilance system, with the sole aim to provide robust patient safety, through monitoring adverse drug reactions, signal detection and risk management plan. Collection, detection, assessment and monitoring of adverse event through  icsr pharmacovigilance  requires specialized IT framework with the capabilities of Intelligent Automation for computing frequency of adverse events using complex algorithms and statistical disproportions, which will help us then to understand the benefit-risk profile of the drug, paving way for an effective risk management plan. With PvPI facilitating drug safety activities in India, In the current scenario there is an strong need for collaboration of IT segment with PvPI to build an in house safety solu...