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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 ...
EMA/199678/2016: Reflection paper on extrapolation of efficacy and safety in paediatric medicine development. [8] EMA/189724/2018: Reflection paper on the use of extrapolation in the development of medicines for paediatrics. [9] EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10]
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
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 ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
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
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.