Literature Safety Monitoring

[@avbviswanath]

Thanks for the videos, new scope of learning

[@chessgold8768]

great and very instructive sir.. thanks a lot..

[@YogeshJadhav-qm2zb]

Amazing video. So much of learning👍

[@jenisharon1076]

It was very informative sir.. Thank u so much..

[@Praveenkumarvarungowda85]

Wonderful explanation of Literature screening... Thank you😊

[@vivekrakha5295]

Clear and concise explanation

[@mudassirsheikh3970]

Thanks for your efforts and conviniance

[@bellyinparis4582]

Thank you, Sir, for your video; I really appreciate it. I have a small question plz: As EMA provides medical literature monitoring using large databases including EMBASE, MEDLINE, IPA and AMED, does the MAH should conduct medical literature monitoring and report adverse events on Eudravigilance for those reported in local journals ? thank you

[@VigiServeAcademy]

Yes, if the ICSR was not reported by any other company

[@bellyinparis4582]

​@@VigiServeAcademy How can I determine if it was reported by another company?

[@VigiServeAcademy]

@@bellyinparis4582 - that is the way Eudravigilance portal works

[@Sanket_2202]

Thank you so much sir. It would really help in my interviews😃.

[@drdinakarkr]

Thank you

[@riajuli3]

Very useful Thanks.

[@nitinpawar9182]

Need to understand the process for literature review for the product marketed in INDIA. We are doing literature review through 2 website Indian Pharmacology and Dermatology sites

[@VigiServeAcademy]

There is no point if these are indexed journals. Look for grey literature or journals published by various organizations (e.g., colleges)

[@0602ify]

For drugs that are on clinical trails, how do we do literature search? Using comparator drugs and what do we look for?

[@VigiServeAcademy]

You can even look for emerging safety issues with the class of drugs

[@anupreetkang3475]

Thanks so much for a detailed video on lit screening for ICSRs. Don't we consider a related/possible causality for a literature article to be valid along with the 4 min criteria?

[@VigiServeAcademy]

Yes, you can consider Author's causality

[@ksravanthi-ge3bg]

Thank you sir....

[@ravitejasambu8533]

As per the USFDA guidelines we search with only the active ingredient irrespective of drug dose, dosage form and strength of the drug as you have covered only regarding the EU guidelines is it true sir

[@VigiServeAcademy]

yes, we have primarily covered the EU/EEA or the GVP VI guideline. The FDA guidelines (the document that talks about this briefly is still in draft) are not very clear in this regard and hence companies prefer a conservative approach.

[@prakash-xb8ck]

Very good session

[@SandeepSingh-ci5cf]

Really Great lesson for Literature Triage, However This was only for ICSR, could you kindly make a lecture on the process of Literature Triage process for aggregate/PSUR. Explain 10 Criteria points for PSUR triage.

[@VigiServeAcademy]

Thanks, Sandeep. Yes, we will consider this in the future.

[@parimalavaskula3706]

Can we have that ppt link for better understanding

[@VigiServeAcademy]

Unfortunately we cannot do that as per our organisation policy