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The electronic common technical document ( eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
fhir .org. The Fast Healthcare Interoperability Resources ( FHIR, / faɪər /, like fire) standard is a set of rules and specifications for exchanging electronic health care data. It is designed to be flexible and adaptable, so that it can be used in a wide range of settings and with different health care information systems.
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...
History. In the 1980s the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
In the United States, Statements on Auditing Standards provide guidance to external auditors on generally accepted auditing standards (abbreviated as GAAS) in regards to auditing a non-public company [1] and issuing a report. They are promulgated by the Auditing Standards Board of the American Institute of Certified Public Accountants (AICPA ...
These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency. USP 800 is an example of a publication created by the United States Pharmacopeia.
Website. gov .uk /mhra. The Medicines and Healthcare products Regulatory Agency ( MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA was formed in 2003 with the merger of the Medicines Control ...
Further reading. Accredited Standards Committee X9, ASC X9 Issues New Standard for Public Key Cryptography/ECDSA, Oct. 6, 2020. Source; Accredited Standards Committee X9, American National Standard X9.62-2005, Public Key Cryptography for the Financial Services Industry, The Elliptic Curve Digital Signature Algorithm (ECDSA), November 16, 2005.