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Now that so many companies are being granted Emergency Use Authorizations (EUAs) for their medical products in response to the coronavirus, how will they (and some existing manufacturers) be expected to report adverse events?]]>
Now that so many companies are being granted Emergency Use Authorizations (EUAs) for their medical products in response to the coronavirus, how will they (and some existing manufacturers) be expected to report adverse events?]]> Wed, 08 Apr 2020 01:26:44 GMT /slideshow/reporting-adverse-events-under-covid19-to-fda/231590357 czomo@slideshare.net(czomo) Reporting adverse events under COVID-19 to FDA czomo Now that so many companies are being granted Emergency Use Authorizations (EUAs) for their medical products in response to the coronavirus, how will they (and some existing manufacturers) be expected to report adverse events? <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/reportingadverseeventsundercovid-19tofda-200408012644-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> Now that so many companies are being granted Emergency Use Authorizations (EUAs) for their medical products in response to the coronavirus, how will they (and some existing manufacturers) be expected to report adverse events?
Reporting adverse events under COVID-19 to FDA from Christine Zomorodian
]]> 303 0 https://cdn.slidesharecdn.com/ss_thumbnails/reportingadverseeventsundercovid-19tofda-200408012644-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://public.slidesharecdn.com/v2/images/profile-picture.png Significant experience in biomedical and technology industries with emphasis on quality systems, process improvement, regulatory affairs, compliant software and process development, project management, healthcare data, and clinical skills. Working knowledge in FDA QSR &amp; cGMP, EU MDD, GAMP, ICH, GHTF, Lean Sigma tools, ISO 9001/13485/14971/17025, DSHEA, HACCP, MDDS, and assorted standards. http://investor.nastech.com/phoenix.zhtml?c=83674&p=irol-newsArticle&ID=495605&highlight=