We process ALL medical journals of the countries where our service is available. We have three reasons why we do not leave a single journal out.
With Comfit, headquarters can have quality control over affiliates without checking their literature monitoring country by country.
Clients can rely on our work and experience: over 20 audits and quality visits that did not reveal any findings in our pro-cedures. Our unique feature is.
to your literature monitoring responsibilities. Be careful how you interpret MLM, or you may risk findings.
EMA posted the following interpretation of the Pharmacovigilance Inspectors Working Group in January 2023: “For ICSRs, medical literature containing the minimum criteria, the clo...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments as well as to make them a part of a check...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments as well as to make them a part of a check...
As we reached the end of our series on questions and GVP references to build and effective literature system, we would like to provide an overview of the topics we touched upon in ...
As GVP is clear that there is “no acceptable loss” (VI.App.2.3.4.) regarding the collection of PV data, ensuring the most reliable search strategy to cover ALL possible...
One of the most challenging parts of reviewing is proving that the frequency and method of checking whether the literature monitoring activities are meeting the GVP timelines is ef...
The GVP dictates that detailed documentation and record keeping for extended period of time is crucial for proving that the literature monitoring process for collecting adverse dru...
At the conference on 17th October 2018, organized by the Hungarian Regulatory Affairs Society (HURAS), the CEO of ComFit Europe Ltd., Katalin Timár-Horváth gave a presentation on...
According to GVP “The marketing authorisation holder has an obligation to review… in the period between the submission of the marketing authorisation application and th...
GVP says “The marketing authorisation holder should establish the most relevant source of published literature for each product.” (VI. App 2.2. Where to look). How do w...
As for literature, GVP says “It is best practice to have selected one or more databases.” (VI. App 2.2. Where to look) It mentions the need to monitor reference databases, loca...
The obligation of literature monitoring for the purpose of pharmacovigilance appears in various topics in GVP. Have a look at the image – this is how we see the relations of ...
Asking the right questions has always been core to problem solving and information gathering. In this blog post we would like to share with you ComFit’s interpretation of thi...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
ComFit Europe is looking forward to the 17th Annual Meeting of the International Society of Pharmacovigilance (ISOP) on 15-18 October in Liverpool with great anticipation. Kati Tim...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
The management of any pharmacovigilance systems can be compared to a worldwide journey. If we decide to see the world, there is no end point to it, just as in PV, learnings and imp...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them to be sources of further developments as well as to make them part of a check ...
