patient safety is paramount to us, and we manage safety data relating to our treatments with the utmost rigor. depending on the country you select, you will be directed to the applicable safety reporting method, either electronically or via locally established mechanisms. if online reporting is available, upon selecting your country you will be directed to the gilead safety information reporting (gsir) tool.
gilead may use this information to contact you and seek such additional information as it may require in order to fulfill its regulatory obligations. gilead will process and use the personal information it records, the health and other information that you provide in relation to the safety event, as well as any additional information which it receives from you in compliance with its obligations related to safety. gilead may share your personal data with vendors appointed by gilead to assist it in the administration of the safety reporting, as well as with the relevant national and/or international regulatory authorities, enforcement, public bodies or courts, where gilead is required to do so by applicable laws, regulations, or at the request of those authorities. depending on which jurisdiction you are in, you may have certain rights and choices regarding gilead’s processing of your personal information, such as the right to require details about the personal information that gilead holds about you, the right of access to your personal information, the right to restrict the processing and use of your personal information and to correct and update it.
the fda adverse event reporting system is a computerized information database designed to support the u.s. food and drug administration’s postmarketing safety surveillance program for all approved drug and therapeutic biologic products. the fda adverse event reporting system (faers) is a database that contains adverse event reports, medication error reports and product the covid-19 eua faers public dashboard provides weekly updates of adverse event reports submitted to faers for drugs and therapeutic ae reporting is based on categorization of the ae according to the seriousness of the event, its expectedness based on product labeling, and presumed causality, adverse event reporting guidelines, adverse event reporting guidelines, adverse event reporting examples, adverse event reporting timelines, adverse event reporting in clinical trials.
have you had a reaction following a vaccination? contact your healthcare provider. report an adverse event using the vaers online form or the downloadable pdf. the adverse event reporting system (aers) is a computerized information database designed to support the food and drug administration’s report an adverse event. patient safety is paramount to us, and we manage safety data relating to our treatments with the utmost rigor., who can report an adverse event, fda adverse event reporting, adverse events database, fda adverse event reporting database, adverse event reporting form, fda adverse event reporting guidance, adverse event definition, fda adverse event reporting form, fda adverse event reporting timelines, fda adverse event definition.
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