Reference Safety Information

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 course 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. 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 will also be reviewed.

This on-demand course takes an average of 2 hours to complete. Learners have access to the course for one year from the date of purchase

• EU RSI requirements
• IND reporting requirements and contrast with EU reporting requirements
• Updating the RSI
• MHRA and the RSI
• Issues with RSI submissions
• Managing IB submissions
• Examples

This course is designed for professionals involved in:

• Clinical safety/pharmacovigilance
• Clinical research
• Document management
• Pharmacology
• Regulatory affairs
• Submissions
• Validation

At the conclusion of this course, participants should be able to:

• Identify the requirements for the use and management of Reference Safety Information in clinical trials
• Recognize how the requirements for RSI  are enforced by regulatory agencies
• Determine compliant RSI processes and documentation