Meddra coding software

Its use is currently mandated in Europe and Japan for safety reporting. Pharmacology literature Pharmacological classification systems. MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary and thesaurus used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. This page was last edited on 30 May , at

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MedDRA - Wikipedia

Free access to all regulators, doctors and academics 11 languages available, almost 3, subscribers from 60 countries. The March Version MedDRA is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans.

SMQs are groupings of terms that relate to a defined medical condition or area of interest. By using this site, you softwate to the Terms of Use and Privacy Policy.

August Learn how and when to remove this template message. Today, its growing use worldwide by regulatory authorities, global pharmaceutical companies, clinical research organisations and health care professionals, allows better global protection of patient health.

Both documents are updated twice a year, with every MedDRA release.

Its use is currently mandated in Europe and Japan for safety reporting. The decisions are made by international medical officers on how to map the terminology within the grouping categories according to a general consensus based on language considerations internationally.

Please help improve this article by adding citations to reliable sources. Views Read Edit View history.

Certified MedDRA Coder

Share this page using your social media account. Unsourced material may be challenged and removed. This page was last edited on 30 Mayat Articles needing additional references from August All articles needing additional references. Individual cases are usually coded for data entry at the most specific LLT level, and outputs of counts or cases are usually provided at the PT level.

MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary and thesaurus used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation.

Certified MedDRA Coder

Retrieved 25 January It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. This article needs additional citations for verification.

Retrieved from " https: Other translations will be considered, should interest be expressed to the MMC. The terminology is free for all regulators worldwide, academics, and health care providers while paid subscriptions meddra on a sliding scale linked to annual turnover of companies.

Products covered by the scope of MedDRA include pharmaceuticals, vaccines and drug-device combination products. From Wikipedia, the free encyclopedia. Pharmacology literature Pharmacological classification systems.

MedDRA is free for regulators and priced according to company revenue for industry.