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Compliant Monitoring of Adverse Events
Posted on May 24th, 2017 by Neal Katz in Pharmacovigilance
Developing and maintaining a solid strategy for screening for adverse events is critical for every pharmaceutical company. Without one, an adverse event could be reported in scientific literature without the company knowing — and failure to report it to the regulatory authorities could result in a serious warning.
The paper “Professional Services: Compliant Monitoring of Adverse Events” introduces us to one of the world’s top pharmaceutical companies. They had missed some articles about adverse events involving their products so they had failed to file the required reports. The regulatory authorities sent them a warning letter as a result. It was clear to the company that they needed to find a new, more reliable strategy for monitoring literature for adverse events right away.
They brought in Elsevier’s Professional Services team who prepared a comprehensive, fully scalable strategy for monitoring literature and performing the necessary triage. The team started by programming search strings to retrieve all of the reports of adverse events and setting up alerts for the results. Next, they designed a triage strategy so that the company’s Drug Safety team could easily review and organize the literature based on relevance. Lastly, Elsevier set up a process to help expedite case triaging.
The strategy gave the company so much confidence that just 15 days after the implementation of the new system, the GPE group at the company called the regulatory agency to request a new audit. The regulatory agency was completely satisfied with new process. And the pharmaceutical company remained more satisfied than ever with the work of Elsevier’s Professional Services team.
All opinions shared in this post are the author’s own.
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