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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]
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.
High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties ...
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.
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.
(The Center Square) – The Georgia Court of Appeals removed Fulton County District Attorney Fani Willis from prosecuting the election interference case against Donald J. Trump and others. The ...
Twelve percent of parents worry that their child’s anger will cause problems, according to a new poll. Experts weigh in on tips to manage their frustrations.
The U.S. Food and Drug Administration [1] [2] and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant ...