Search results
Results from the WOW.Com Content Network
Mutual recognition of inspection between member countries, so that an inspection carried out by officials of one member country will be recognized as valid by other members. Equivalent principles of inspection methodology, so that it is understood that inspectors in each member country will be following the same best practices when carrying out ...
Creation of a TMF and inclusion of ICH essential documents is based on the discretion of the regulatory agency for the country in which the clinical trial is conducted. In addition, the submission of a marketing application will normally require compliance with the regulatory requirements of that country, including requirements specific to TMF ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
The single submission process for approval to conduct research in all EU member states is facilitated by the Clinical Trials Information System (CTIS). [3] CTIS is an online portal which enables interactions between clinical trial sponsors (that is, the organization responsible for the conduct of the clinical trial), and the regulatory ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
Raw samples nationwide will now be collected and shared with the U.S. Department of Agriculture in order to test for bird flu, according to a new federal order issued by the agency on Friday.
Several countries are considering termination on the use of inspection companies' service, following upon WTO Agreement on Trade Facilitation Article 10.5 Pre-shipment Inspection : 5.1. Members shall not require the use of pre-shipment inspections in relation to tariff classification and customs valuation.