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Audit Contingency & Form 483

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 observation’ and ‘Factory Inspection’,it is th…
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The ‘new’ EUDRAVIGILANCE

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 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 9560102587, +91 9810068241 or email us…

INDIA- A need to develop our own In house safety database solution

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’s (Individual Case Safety Reports) 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 solution which wi…

Drug Safety and Br-exit

There have been talks about what would happen once UK leaves EU which has put lot of QPPV (Qualified Persons Responsible for Pharmacovigilance) in UK in dilemma as the regulations say that the QPPV should be a part of the EU, with the impact Brexit it will hit the pharmacovigilance system in UK as EU would not be obliged to carry out Post marketing surveillance in UK. Currently June Raine who is chairing the Pharmacovigilance Risk Assessment Committee ( part of the European Medical Agency, in which there are two members from each member state) is from the Medicines and healthcare products regulatory agency (MHRA) of the UK. There have been discussions about QPPV who still want to be a part of EU which might eventually lead to a negotiation between EMA and UK to collaborate pharmacovigilance activities together, as pharmacovigilance is above politics
By Joseph Mathew Sr. Manager- Think i About us: We are an organization providing technological solutions and result oriented quality servic…