Reference Safety Information – how to avoid problems                  

 A recording of the webinar held on Wednesday 10 March 2021@ 1 pm GMT (UK) 2pm CET (Copenhagen)  8am EST (Boston) and lasting approx. 90 mins

RSI is one of the current inspection hot topics (both GCP and PV) and often leads to critical findings.

This webinar is for those in clinical research and safety departments who need to know about the RSI.
It consists of a presentation followed by a panel discussion involving experts in the field.

Prof David Hutchinson (Brookwood)
Dr Raj Bhogal, Sr. Director, R&D Audits & Inspections, Jazz Pharmaceuticals
Dr Mircea Ciuca, Global Therapeutic Area Head, Global Clinical Safety and PV, CSL Behring

• What is the RSI,  what does it contain?
• RSI and the Investigator’s Brochure.
• Version controls.
• Cross-functional involvement.
• How is the RSI used?
• Causality v expectedness.
• Who can make expectedness evaluations?
• What are the most common inspection findings and how can you avoid them?
• Your questions – we will stay on as long as it takes to answer your questions!