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The content and the format for drug master file used in United States differs from that used in European Countries to obtain market authorization (MA). The Main Objective of the EDMF is to support regulatory requirements of a medicinal product to prove its quality, safety and efficacy. This helps to obtain a Marketing Authorisation grant.
The American Medical Association (AMA) Physician Professional Data (formerly known as the AMA Physician Masterfile) includes current and historical data on all physicians, including AMA members and nonmembers, and graduates of foreign medical schools who reside in the United States and who have met the educational and credentialing requirements necessary for recognition as physicians. [1]
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Whilst the DIA doesn't have a formal, public and open standards effort in place to develop a formal, published standard, the use of the Reference Model is helping industry to standardize on the content of the trial master file, on the nomenclature for trial master file artifacts and on the taxonomy used.
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. 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.
This certification is mainly for compliance staff, HIPAA consultants, HIPAA auditors and HIPAA Compliance officer. Certified Health Physicist CHP Certification as a professional health physicist awarded by the American Board of Health Physics and the American Academy of Health Physics. [56] Diplomate of the American Board of Health Physics DABHP
The American Board of Toxicology is the oldest and largest certification body in the world to ensure the competency of toxicologists involved in preclinical drug discovery. [5] Board certification is available to a licensed attorney in the United States as well, although it generally is not considered a form of licensure and usually does not ...
Drug companies were required to show proof of the effectiveness of their drugs to advertise them in AMA's journal. [38] In 1906, the AMA established a Physician Masterfile designed to contain data on physicians in the United States as well as graduates of American medical schools and international graduates who are in the United States. Each ...