In Pharmacovigilance -Case processing after completing the data entry process and before routing the case to the next workflow (Medical Review), it is mandatory for everyone to do a Validation check called as E2B validation, E2B validation error could also be an error associated with a special character in case study narrative or in adverse event, further if an error is reported on Validation check which cannot be rectified, a comment stating ‘E2B validation was noted and bypassed’ should be used contact log Every wondered why? Every ICSR (Individual case safety report) as per 21 CFR 314.80 in US and Schedule Y appendix XI in India, should be transmitted from the reporting sources to the regulatory authority and this process is also known as E2B submission (as we submitting E2B files) and because one of the mode of transmission is via XML format, if a special character found in the ICSR which is not rectified after the ICSR is converted into an XML file and upload as an...

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...

We have quite often heard about the contingency plan for an Audit, especially when it is a regulatory inspection, like by the US FDA (United States Food and Drug Administration) or MHRA (Medicines and healthcare product regulatory agency).  Claris recently underwent a regulatory inspection by the US FDA and was given the green flag with no observations reported. With compliance being the utmost priority for every inspection, it has become essential for every Marketing Authorization Holder (MAH) to have an audit response team, which would capable and qualified to understand all the norms and requisites for a regulatory visit. Over the past several years it has been observed that FDA has been proactive in constantly monitoring ADR and compliance which has led it’s issuing of ‘Form 483 warning letters and citations’ to many companies.  Form 483 refers to the 21 United States Code (USC) part 374 which authorizes US FDA to conduct ‘Inspectional obs...

European Medical Agency would be releasing a new version of EudraVigilance system, which is expected to go live in November 2017, EMA in their report mentioned that they would be publishing a checklist of readiness for all the stakeholders to prepare them for the changes which will come along with the launch of the revised version of EudraVigilance, for which EMA also intends to provide eLearning modules, support webinars and face to face training. The prototype of EudraVigilance test environment or XCOMP is already scheduled to be released June 2017 which will let all the National competent authorities to test Individual case safety reports in E2B R3 versions. 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 friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event.  For more details, contact us at +91 ...

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...