Definitions
from Wiktionary, Creative Commons Attribution/Share-Alike License.
- noun
Abbreviation of Medical Dictionary for Regulatory Activities; medical terminology used by regulatory authorities and the regulatedbiopharmaceutical industry, including adverse event classification.
Etymologies
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Examples
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Experience with commercial databases and safety coding dictionaries MedDRA, WHOART, COSTART, etc.
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Familiarity with US/ICH regulatory safety reporting requirements/guidelines, safety database, and MedDRA coding
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Initiate MedDRA coding of adverse events in the safety database.
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• Understanding of medical coding processes, in particular use of MedDRA and
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EXTEDO PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables users to classify, create, review, submit, and maintain
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Provide timely and accurate medical evaluation of individual and aggregated safety data from pre - and post-authorization sources including correct MedDRA coding of adverse events from assigned cases
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• Understanding of medical coding processes, in particular use of MedDRA and
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EXTEDO PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables users to classify, create, review, submit, and maintain
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EXTEDO PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables users to classify, create, review, submit, and maintain
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Adverse events were classified by body system using the Medical Dictionary for Regulatory Activities (MedDRA), and tabulated based on the incidence, severity, and causality to study treatment.
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