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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.
In February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015." [ 11 ] The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be ...
A review of issues implicated in the re-opening of dental services (practice preparation, personal protective equipment, management of the clinical area, dental procedures, and cleaning and disinfection) indicated that patient triage by telephone is recommended by several research groups, while some also recommend temperature screening at ...
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.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
With 13 million children and adults enrolled, Denti-Cal is the largest state-sponsored dental insurance program; Private contractor that administers Denti-Cal is Delta Dental. In 2016, the State of California awarded Delta Dental a new contract to provide administrative services for the Denti-Cal program, continuing the 42-year relationship [7]
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 ...
Much less attention is paid to both the other two spheres of EBD, clinical expertise and patient values. [8]Clinical expertise plays a part in the successful outcomes of treatment with diagnostic skills preventing over and under-treatments, technical dental skills maximizing the longevity of surgical and restorative procedures and communication skills being core to patient management and ...