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Diez O.,European Medicines Agency EMA | Silva A.,Technical University of Madrid
Quality and Reliability Engineering International | Year: 2014

With the increasing utilisation of Internet services and cloud computing by many organisations (both private and public), it is clear that computing is becoming the fifth utility (along with water, electricity, telephony and gas). These technologies are used for almost all types of systems, and critical systems are now no exception. Even if critical systems appear not to rely directly on cloud services, there may be hidden interdependencies that could affect their resilience. This paper investigates the uses of cloud computing in relation to critical systems and how this affects their resilience, initially comparing it with existing models and frameworks. Some examples are presented together with the associated risks. A framework is introduced for analysing the dependability and resilience of a system that relies on cloud services and how to improve them. As part of the framework, the concepts of micro and macro dependability are introduced to explain the internal and external dependability on services supplied by an external cloud. A pharmacovigilance model system has been used for framework validation. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd. Source

Davies E.H.,University College London | Saint Raymond A.,European Medicines Agency EMA
European Journal of Clinical Pharmacology | Year: 2010

Purpose: To examine the early impact of the Paediatric Regulation, which entered into force in Europe on 27 January 2007, on the development of pharmaceutical drugs in the therapeutic field of pain submitted to the Paediatric Committee (PDCO) and to the European Medicines Agency (EMA). Methods: Paediatric Investigations Plans (PIPs) submitted with a Decision (outcome) reached between September 2007 and March 2010 were included in the analysis. Results: Of the 17 Paediatric Investigation Plans submitted, 14 have resulted in an EMA Decision, 3 were withdrawn by the applicants, 8 were granted a full waiver from development, and 1 resulted in a negative opinion. Decisions as issued included 15 clinical trials, with at least 1,282 children to be recruited into studies across five different products. Neonates were included in four of the products. Conclusions: The small number of submissions indicates a lack of new drugs being developed for the management of pain. Ethical concerns that too many vulnerable children will be recruited into clinical trials must be balanced against limiting the number of off-label prescribing and obtaining age-appropriate information on paediatric use. Now is an opportune time for clinicians, academics, learned societies and industry to collaborate for the benefit of children in pain. © 2010 Springer-Verlag. Source

Koenig F.,Medical University of Vienna | Slattery J.,European Medicines Agency EMA | Groves T.,BMJ | Lang T.,AGES Austrian Agency for Health and Food Safety | And 4 more authors.
Biometrical Journal | Year: 2015

In recent months one of the most controversially discussed topics among regulatory agencies, the pharmaceutical industry, journal editors, and academia has been the sharing of patient-level clinical trial data. Several projects have been started such as the European Medicines Agencýs (EMA) "proactive publication of clinical trial data", the BMJ open data campaign, or the AllTrials initiative. The executive director of the EMA, Dr. Guido Rasi, has recently announced that clinical trial data on patient level will be published from 2014 onwards (although it has since been delayed). The EMA draft policy on proactive access to clinical trial data was published at the end of June 2013 and open for public consultation until the end of September 2013. These initiatives will change the landscape of drug development and publication of medical research. They provide unprecedented opportunities for research and research synthesis, but pose new challenges for regulatory authorities, sponsors, scientific journals, and the public. Besides these general aspects, data sharing also entails intricate biostatistical questions such as problems of multiplicity. An important issue in this respect is the interpretation of multiple statistical analyses, both prospective and retrospective. Expertise in biostatistics is needed to assess the interpretation of such multiple analyses, for example, in the context of regulatory decision-making by optimizing procedural guidance and sophisticated analysis methods. © 2014 The Author. Biometrical Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. Source

Isaac M.,European Medicines Agency EMA | Gispen-de Wied C.,Medicines Evaluation Board MEB
European Neuropsychopharmacology | Year: 2015

Our objectives are to describe the procedure for qualification advice and opinion from EU regulators on the use of novel methodologies in drug development, the key stakeholders involved and the evidence requirements for qualification opinion.We present a case study of the request from the Coalition Against Major Disease (CAMD) Consortium of the Critical Path (C-Path) Institute for EU regulators' qualification opinion on the use of low hippocampal volume as a biomarker for population enrichment in clinical trials of novel drugs in Alzheimer's disease (AD). We discuss the main concerns from the regulators, data analysis requests and guidance during the qualification.EU regulators concluded that low hippocampal volume, measured by vMRI and considered as a dichotomized variable (low volume or not), appears to help enriching recruitment into clinical trials aimed at studying drugs that potentially slow the progression of the pre-dementia stage of AD.The biomarker qualification procedure is a dynamic process in which pharmaceutical companies and research consortia can submit further data to update the qualifications and improve the predictive value of the biomarkers. © 2015 Elsevier B.V. and ECNP. Source

Diez O.,European Medicines Agency EMA | Silva A.,Technical University of Madrid
IEEE Technology and Society Magazine | Year: 2013

Cloud services might provide benefits for public organizations, but governments have been slow to adopt their use. The main indirect benefits of the use of cloud services in public organizations will come from the use of app stores and social media. The first will permit re-use of software and services, mainly when using SaaS and PaaS, permitting rapid deployment of new functionality. The use of social media and collaboration directly with users could permit a new paradigm in the way the public services are used by the public, allowing users to add and manipulate data and even applications that will use the data. In order to accomplish this change successfully it is very important that public bodies work together with providers defining proper standards and services that meet the requirements of public bodies. Amazon GovCloud for the U.S. is one such public cloud service that ensures data do not leave the U.S. and that the service complies with FISMA (The Federal Information Security Management Act of 202) moderated controls. Source

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