EMA posted the following interpretation of the Pharmacovigilance Inspectors Working Group in January 2023: “For ICSRs, medical literature containing the minimum criteria, the clock...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments...
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments...
As we reached the end of our series on questions and GVP references to build and effective literature system, we would like to...
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...
One of the most challenging parts of reviewing is proving that the frequency and method of checking whether the literature monitoring activities are...
The GVP dictates that detailed documentation and record keeping for extended period of time is crucial for proving that the literature monitoring process...
At the conference on 17th October 2018, organized by the Hungarian Regulatory Affairs Society (HURAS), the CEO of ComFit Europe Ltd., Katalin Timár-Horváth...
According to GVP "The marketing authorisation holder has an obligation to review...
GVP says "The marketing authorisation holder should establish the most relevant source of published literature for each product." (VI. App 2.2. Where to...