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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.
Consider the primary and ancillary detail of the proposed change. This should include aspects such as identifying the change, its owner(s), how it will be communicated and executed, [8] how success will be verified, the change's estimate of importance, its added value, its conformity to business and industry standards, and its target date for completion.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
ISO 15489 Information and documentation—Records management is an international standard for the management of business records, consisting of two (2) parts: Part 1: Concepts and principles and Part 2: Guidelines. [1]
Methods of administration Safety monitoring procedures An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a ...
A couple in Australia have been accused of faking their young son's cancer diagnosis "It will be alleged that the accused shaved their 6-year-old child’s head, eyebrows, placed him in a ...
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It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act ...