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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 ...
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.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
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.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
A frequently asked questions (FAQ) list is often used in articles, websites, email lists, and online forums where common questions tend to recur, for example through posts or queries by new users related to common knowledge gaps.
Piazza is a learning management system which allows students to ask questions in a forum-type format.Instructors are able to moderate the discussion, along with endorsing accurate answers.
In the other five trials (NCT01930188, [54] NCT01885208, [55] NCT02128932, [56] NCT02207374, [57] and NCT02254291 [58]), participants were randomly assigned to receive either semaglutide or another anti-diabetic medication, and the participant and provider knew which medication was being given in four trials. [29] Treatment was given for 30 ...