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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 ).
Design space verification is a part of process validation as defined by the EMA in conjunction with the FDA. Its purpose is to guarantee end product quality within a range of manufacturing boundaries. The effects of scale up activities should be fully understood by the manufacturer.
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
Contains extensive information on over-the-counter drugs and their responsible use, including specific guidance on several drug classes in question-and-answer format and information on common drug interactions. UK Medicines and Healthcare Products Regulatory Agency list of substances on general sales list Archived 2014-03-07 at the Wayback Machine
The experience sampling method (ESM), [1] also referred to as a daily diary method, or ecological momentary assessment (EMA), is an intensive longitudinal research methodology that involves asking participants to report on their thoughts, feelings, behaviors, and/or environment on multiple occasions over time. [2]
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]).
The EMA was founded in October 2001 by a group of electronic money issuers and prospective issuers to represent the interests of industry. The group took part in a regulatory working group set up in response to UK government consultation on the implementation of the E-Money Directive .