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.