Drugmakers should have a structured and recognized methodology for assessing evidence in an adverse reaction report, taking into account such factors as clinical relevance, quantitative strength of the association and the exposure-response association, according to a draft European Medicines Agency (EMA) guideline.
Statistical analysis of signals picked up in large databases of spontaneous reports can help identify disproportionate reporting. However, it may not indicate a need for further investigation, the draft states. Further, the frequency at which drugmakers should compile and review statistical reports may vary depending on the drug, its use and known risks, it adds.
For a signal to become validated, all relevant documentation must suggest a new potentially causal relationship or new aspect of a known association that justifies further evaluation, according to the draft.
The document discusses requirements for managing signal detection and is one of seven good pharmacovigilance practice modules aimed at preparing drugmakers for new pharmacovigilance legislation (Directive 2010/84/EU) which took effect July 1.
Meanwhile, in the U.S., Congress has given the FDA greater authority in pharmaceutical safety regulation in response to major safety-related drug withdrawals.
Even if you think you know regulators’ latest thinking on postmarket pharmacovigilance, clinical trial safety, adverse event reporting and REMS, you could be working under false assumptions — using outdated practices that could set you up for serious penalties.
But there is no need to fret, in two days you can dive into a workshop that will enhance your safety signal detection, evaluation and management skills.
Safety Signal Detection, Evaluation and Associated Actions: Assessing and Managing Risk Throughout the Drug and Biologics Lifecycle is a must-attend conference that will explain the vital role of clinical case assessment in signal evaluation, identify the underlying principles of signal detection and so much more.
You’ll leave this workshop a much better risk management professional, so don’t delay. Register for this end-of-August workshop today!