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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.
A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.
The World Dental Federation guidelines highlight that operators of dental radiography equipment must be sufficiently trained and qualified. When operating equipment, the staff member should be at least two metres away from the source, clear from the primary beam and behind a protective shield or wall where possible. [ 2 ]
Based upon the work of the international AGREE Collaboration for the quality of clinical practice guidelines, [3] an organised network for organisations and experts working in the field of evidence-based guidelines was proposed in early 2002 at the first international guideline conference in Berlin, Germany. [4]
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.
Chrome-cobalt disc with bridges and crowns manufactured using WorkNC Dental CAD/CAM. CAD/CAM dentistry is a field of dentistry and prosthodontics using CAD/CAM (computer-aided-design and computer-aided-manufacturing) to improve the design and creation of dental restorations, [1] [2] especially dental prostheses, including crowns, crown lays, veneers, inlays and onlays, fixed dental prostheses ...
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...