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The ASAP Process supports the Safety Surveillance Plan
The 2021 IND safety reporting guidance highlights the importance of maintaining a Safety Surveillance Plan (SSP) that describes the approach for monitoring serious anticipated events requiring aggregate analysis. Decisionmaking for…
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A Learning and Decision Making Approach
A Learning and Decision-Making Approach PhRMA SPERT proposed three tiers (classifying endpoints by analysis) for analyzing AEs. An alternative approach is to think of two parts (classifying endpoints by clinical…
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The ASAP Process Builds on CIOMS VI and the PSAP
In 2005, CIOMS VI (Management of Safety Information from Clinical Trials) started to bridge the gap between pre- and post-approval activities to understand and manage risk. Pharmacovigilance had traditionally focused…
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Regaining Global Alignment on Safety Reporting from Clinical Trials
EU regulators prefer to receive all individual SUSAR reports from sponsors (judged by sponsor and/or investigator) – concerned about missing important signals. Note, Reference Safety Information (RSI) listed in the…
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Global Regulatory Landscape for Aggregate Safety Assessments
Recent guidance on safety monitoring during drug development, issued by regulatory authorities in the US and EU, indicate a shift in focus toward aggregate safety monitoring and scientific evaluation of…
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When Quant Is Not Enough
To meet the spirit of the IND safety reporting final rule, sponsors have developed processes and procedures to evaluate, assess and act on accumulating safety information during development on an…