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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.
The main editions also can take the form of one of the following special editions: N and KN editions The features in the N and KN Editions are the same as their equivalent full versions, but do not include Windows Media Player or other Windows Media-related technologies, such as Windows Media Center and Windows DVD Maker due to limitations set by the European Union and South Korea ...
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The International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [1] [2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [3] and Switzerland. [1]
ISO 14644-4: Design, Construction, and Start-up [3] ISO 14644-5: Operations [3] ISO 14644-6: Vocabulary [3] ISO 14644-7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments [3] ISO 14644-8:2022(en), Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness for chemical concentration ...