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Small Pharma Advanced Safety Analytics Proof Points
Large pharma, small pharma- same regulations, suprisingly different approaches and needs. As a consultant, I specialize in helping small pharma easily, efficiently, and affordably incorporate advanced safety analytics that serve…
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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…