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.

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