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SUNDAY, JANUARY 27 | 9:00AM-12:30PM

This half-day short course will be conducted in two parts. The first part will focus on the basic aspects of the EU regulation and EU guidances (including Q&A documents) that govern the content, placement, use, and management of the Reference Safety Information as used in assessing expectedness of “suspected” serious adverse reactions (SARs) from clinical trials. The second part will focus on the practical aspects of implementing the regulations and guidances, including a review of acceptable and non-acceptable examples of the RSI and examples of regulatory agency inspection findings related to the RSI.

*Short Courses are not included in the meeting registration and require a separate fee.

Return to Pharmacovigilance and Risk Management Strategies.

Learning objectives

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 as described in the CTFG Q&A document are enforced by regulatory agencies
  • Be able to develop compliant RSI processes and documentation