Search results
Results from the WOW.Com Content Network
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 ...
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
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.
The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied with the product is aimed at end-users. [3]
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]
The Dental Procedure Education System (DPES), is a web-based resource containing a collection of procedures from the dental disciplines.The procedures presented in DPES were developed [when?] by individual faculty members at the Faculty of Dentistry, University of Toronto, in collaboration with a group of educational media and technology experts.
Current Dental Terminology (CDT) is a code set with descriptive terms developed and updated by the American Dental Association (ADA) for reporting dental services and procedures to dental benefits plans. [1] [2] [3] Prior to 2010 many of the codes were published by Centers for Medicare and Medicaid Services (CMS) as HCPCS D-codes under ...