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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 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]).
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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.
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.
Questions and Answers or Voprosy I Otvety, a Russian game-show channel; Questions and Answers (TV programme), an Irish topical debate show "Questions and Answers" (The Golden Girls), a television episode
As of 26 March 2020, 1.7 billion people worldwide were under some form of lockdown. [267] This increased to 3.9 billion people by the first week of April—more than half the world's population. [268] [269] In several countries, protests rose against restrictions such as lockdowns. A February 2021 study found that protests against restrictions ...
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).