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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
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 ).
Enterprise mobility management is a set of systems intended to prevent unauthorized access to enterprise applications and/or corporate data on mobile devices. These can include password protection, encryption and/or remote wipe technology, which allows an administrator to delete all data from a misplaced device.
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.
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]).
Clients are management software applications that can reside virtually anywhere within a network, provided they have a communications link (either within the data path or outside the data path) to providers. Servers are the devices under management. Servers can be disk arrays, virtualization engines, host bus adapters, switches, tape drives, etc.
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Citing the plethora of mobile devices in the enterprise – and a growing demand for mobile apps from employees, line-of-business decision-makers, and customers – the report states that organizations are broadening their "mobility strategy" beyond mobile device management to "managing a growing number of mobile applications". [9]