Ensuring compliant Monitoring of Adverse Events
Compliance is critical — because missing adverse events is simply not an option
Every pharmaceutical company needs a solid strategy for screening scientific literature for adverse events involving their products. Missing an adverse event or a reporting deadline will lead to serious responses from regulatory authorities. Find out how Elsevier R&D Professional Services helped one pharmaceutical company become more compliant with literature screening requirements.
One of the world’s top pharmaceutical companies received a warning letter from the regulatory authorities. They had missed some articles that mentioned adverse events involving their products and, as a result, had not filed the required reports. The company needed to find a new, more certain strategy for monitoring scientific literature.
Elsevier’s Professional Services team was able to prepare a fully scalable strategy for literature monitoring and triage that met the company’s needs. First, the team programmed search strings to retrieve all of the reports of adverse events matching the desired drugs and therapeutic conditions and applied them to the Embase database, which includes MEDLINE®. Alerts were set up to automate the delivery of search results. Next, the team set up a triage strategy that allows the company’s Drug Safety team to easily review and define the relevance of the literature and organize it using QUOSA. Lastly, Elsevier set up a process to help expedite case triaging.
"Searches must be broad enough to capture everything relevant, but that yields extensive results. So the triage method must enable users to quickly and accurately sift through those results."
Just 15 days after the implementation of the new system, the GPE group at the company felt confident enough to call for a new audit, which was performed 6 months later. The results fully satisfied the concerns of the regulatory agency. This is the type of confidence in strategy design that is essential for regulatory and medical affairs teams at pharmaceutical companies. And it’s precisely the kind of confidence that Elsevier’s Professional Services team provides.
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