CRED Understanding Clinical Development 2024

09/10/2024

Expectedness/ Reference safety Information

• Expectedness assessments are from the perspective of events previously observed with the IMP and not what you might expect based on the pharmacological properties of the drug • Assessment is against the RSI which is contained in the IB, the SmPC or Core datasheet • Information in these documents must be clearly identified as the RSI and provided in the protocol and cover letter for the CTA. • An update to RSI has to be approved by the CA before it can be used for assessment. • RSI reviewed at least annually at the time of the DSUR .

The Organisation for Professionals in Regulatory Affairs

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Regulatory reporting (EU)

Expedited reporting

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• Serious unexpected ADRS are reported to regulatory authorities • Within 7 days for fatal/ life threatening events • 15 days for other serious events • SUSARS (EU) • Aggregate reporting

• Developmental Safety Update Report

• Ethics committees and investigators are also notified according to local requirements

The Organisation for Professionals in Regulatory Affairs

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