The implementation of the EU requirements for the use of Reference Safety Information (RSI) in determining expectedness of “suspected” serious adverse reactions (SARs) from clinical trials continues to be challenging. This half-day short course will be conducted in two parts. The first part will focus, at a high level, on the basic aspects of the EU Regulation and EU Guidance (including Q&A Documents) that govern the content, placement, use, and management of the Reference Safety Information and compare/contrast with the US FDA approach to assessing expectedness and causality to determine reportability of individual clinical trial cases. The second part will focus on practical aspects of implementing the regulations and guidance, criteria for updating the RSI, UK MHRA approach following Brexit and a review of acceptable and non-acceptable examples of the RSI.
At the conclusion of this short course, participants should be able to:
- Describe the requirements for the use and management of the RSI in clinical trials
- Understand how the requirements for RSI are enforced by regulatory agencies
- Be able to develop compliant RSI processes and documentation