We won the Visa She’s Next 2025 award
Proud to share that we are one of the winners of Visa She’s Next 2025. This program recognizes women-led businesses that have already proven...
08 július, 2025
/ 0 Comments
BLOG
EMA say: day zero starts at receipt of physical/hard copy local journals! Implications: contradictions with GVP, low impact on patient safety, higher costs for MAH
EMA posted the following interpretation of the Pharmacovigilance Inspectors Working Group in January 2023: “For ICSRs, medical literature containing the minimum criteria, the clock...
08 február, 2023
/ 0 Comments
AUDIT LEARNINGS – Training of personnel involved in the literature reviewing process
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments...
27 november, 2018
/ 0 Comments
AUDIT LEARNINGS – Keeping track of the monitored journal list
At ComFit, we have been collecting the questions of audits and quality checks for years and turn them into sources of further developments...
13 november, 2018
/ 0 Comments
7 Questions + 7 Answers = A Brief Guide to an Effective Literature Monitoring System
As we reached the end of our series on questions and GVP references to build and effective literature system, we would like to...
06 november, 2018
/ 0 Comments
HOW do you successfully SEARCH for PV data without missing anything?
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...
30 október, 2018
/ 0 Comments
WHEN to carry out literature monitoring
One of the most challenging parts of reviewing is proving that the frequency and method of checking whether the literature monitoring activities are...
25 október, 2018
/ 0 Comments
HOW do you DOCUMENT successfully the literature monitoring activities?
The GVP dictates that detailed documentation and record keeping for extended period of time is crucial for proving that the literature monitoring process...
24 október, 2018
/ 0 Comments
Consultation about the recommended Hungarian local medical literature list (PV Conference by HURAS – 17th Oct 2018)
At the conference on 17th October 2018, organized by the Hungarian Regulatory Affairs Society (HURAS), the CEO of ComFit Europe Ltd., Katalin Timár-Horváth...
18 október, 2018
/ 0 Comments
HOW do you prove WHICH drugs have been monitored in a given period of time?
According to GVP "The marketing authorisation holder has an obligation to review...
16 október, 2018
/ 0 Comments