On Friday, 22 September 2017, a GCP/GPV training day was held with the subject: "Safety Information from a GCP Perspective".

The day started with a presentation on “Core concepts in pharmacovigilance auditing” by Marielle Keulen, Xendo. It was followed by presentations which covered different aspects of Safety information which included Reference Safety Information (RSI) from Clinical Trial and Post marketing perspectives, presented by Deepti Naik, PRA Health Sciences and Marielle Keulen.

Pharmacovigilance aspects which one comes across during day to day GCP or during monitoring was presented by Deepti Naik in her presentation “Safety information at investigator sites” hereby linking GCP and GPV. Final presentation for the day was on “Reference Safety Information from a QA perspective” presented by Laurentiu Chitimia, Astellas. The day concluded with a Q&A session with the speakers of the day.

Points of discussion were:

  • RSI- its importance and criticality
  • Changes to the regulations with regards to RSI
  • Commonly observed issues and audit findings related to RSI

Around 35 participants from different backgrounds including QA, Pharmacovigilance Operations attended the training day. The cross functionality of the topic linking GCP and GVP and the wide range of the audience backgrounds lead to lively discussions and a very interactive training day.

The presentations of this day are now available for download for our members. Sign in first and go to https://www.darqa.org/downloads/category/46-2017

The non-DARQA members who were present can send an email to the Dit e-mailadres wordt beveiligd tegen spambots. JavaScript dient ingeschakeld te zijn om het te bekijken. for sending the presentations.