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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.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
However, work stalled on the project. An additional Draft Implementation Guide was released in February 2015 [5] The ICH and the FDA released draft specifications and guides in April 2016, and on May 13 there was an ICH "teleconference" to discuss the guidance and any queries or clarifications that might be necessary. [6]
Evidence-based dentistry (EBD) is the dental part of the more general movement toward evidence-based medicine and other evidence-based practices. The pervasive access to information on the internet includes different aspects of dentistry for both the dentists and patients.
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.
Vol. 1: Pharmaceutical legislation: medicinal products for human use. ISBN 92-828-2032-7; Vol. 2: Notice to applicants: medicinal products for human use. ISBN 0-11-975780-X; Vol. 3: Guidelines: medicinal products for human use. ISBN 92-828-2436-5; Vol. 4: Good manufacturing practices: medicinal products for human and veterinary use. ISBN 92-828 ...
By the late 1980s, BFS had been well-established in the packaging industry, especially for packaging pharmaceutical and healthcare products. [14] During the 1980s and 1990s, BFS came into use for the now common small volume unit-dosage forms. [12] Since the early 2000s, BFS has been emerging as the preferred packaging process for parenteral ...
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 clinical trial.