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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 ...
The laboratories that form the network share resources, expertise and workloads: this not only contributes to reducing public health expenditure, a broader coverage of medicines on the market and to the development of future harmonised common standards, but means that laboratories across Europe have access to state-of-the-art technology and ...
EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.
A question and answer system (or Q&A system) is an online software system that attempts to answer questions asked by users.Q&A software is frequently integrated by large and specialist corporations and tends to be implemented as a community that allows users in similar fields to discuss questions and provide answers to common and specialist questions.
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.
Windows Forms, also known as Winforms, is a free, open-source graphical user interface (GUI) class library for building Windows desktop applications, included as a part of Microsoft.NET, .NET Framework or Mono, [2] providing a platform to write client applications for desktop, laptop, and tablet PCs. [3]
The most commonly filed SEC forms are the 10-K and the 10-Q. These forms are composed of four main sections: The business section, the F-pages, the Risk Factors, and the MD&A. The business section provides an overview of the Company. The F-pages contain the financial statements which are either audited or reviewed by an independent auditor.
Quantum satis (abbreviation q.s. or Q.S.) is a Latin term meaning the amount which is enough.It has its origins as a quantity specification in medicine and pharmacology, [citation needed] where a similar term quantum sufficit ("as much as is sufficient") has been used (abbreviated Q.S.). [1]