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Sweden as a research country Research plays an important role as an engine for growth in both the global and the Swedish economy. Medical research shall contribute to better health, increased quality of life and decreased societal cost. Research is
Last modified: 2018-11-13 16.01
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Phase 1 units for clinical trials with medicines The first phase in a clinical trials programme for medicines is called Phase 1. If it is the first time a new medicine is given to a human being, the study is called a First-in-Human trial. A trial
Last modified: 2018-05-24 11.10
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For researchers The “For researchers” pages are primarily aimed at researchers who want to conduct or learn more about clinical studies. Here you can find information about the study process, different study types and the laws and regulations that
Last modified: 2019-01-16 15.29
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Specific rules for medical devices Writing a final report Visa mer Visa mindre Writing a final report When a study requires a permit from the Swedish Medical Products Agency, you must write a final report that is available on request, according to
Last modified: 2019-01-15 13.47
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Archiving When a clinical study is completed, research materials including data and documentation need to be prepared for long-term storage. It is important to research documents are stored and archived in a structured way in order to enable scrutiny
Last modified: 2019-01-15 13.48
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Specific rules for medicines Archiving clinical trials with medicines Visa mer Visa mindre Archiving clinical trials with medicines The research documents that clinical investigators and sponsors are obliged to draw up and store before and during a
Last modified: 2019-01-15 13.48
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Specific rules for medical devices What shall be archived? Visa mer Visa mindre What shall be archived? Please contact the information owner for information about what is to be archived in your particular study. In general, the sponsor of a study
Last modified: 2019-01-15 13.48
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The Act concerning the Ethical Review of Research Involving Humans The Act concerning the Ethical Review of Research Involving Humans (2006:460) came into force on 1 January 2004. The purpose of the Act is to protect the individual person and ensure
Last modified: 2019-02-11 10.18
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Cooperation on quality systems and work processes The project has been tasked to map quality systems within the various participating nodes, and, based on these, to develop proposals for opportunities for synergies and follow-up projects. The aim is
Last modified: 2018-04-10 10.38
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Coordination of feasibilities The purpose is to increase the number of clinical studies in Sweden by coordination study requests nationally, regionally and locally via the regional nodes. The aim is to improve the ability to provide quick,
Last modified: 2018-09-04 11.21
Search this site
Your search resulted in 7 hits
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Sweden research country
Sweden as a research country Research plays an important role as an engine for growth in both the global and the Swedish economy. Medical research shall contribute to better health, increased quality of life and decreased societal cost. Research is
Last modified: 2018-11-13 -
Sweden research country
for clinical trials with medicines The first phase in a clinical trials programme for medicines is called Phase 1. If it is the first time a new medicine is given to a human being, the study is called a First-in-Human trial. A trial
Forum Uppsala-Örebro Karolinska Trial Alliance Gothia Forum Forum South Sweden Study phases FeasibilityLast modified: 2018-05-24 -
News
The new Data Protection Ordinance will be applied as from 25 May 2018. A subsidiary report includes an analysis of the regulation of personal data handling for research purposes that is possible
Last modified: 2017-11-27 -
News
In conjunction with the Council of Europe deciding on a new directive for clinical therapy studies using medicines, the Swedish Medical Products Agency and the regional ethical
Last modified: 2017-11-27 -
News
On Friday 26 May, two new medical technology directives come into force. The new legislation has been negotiated within the EU. The purpose of the directives adopted – one for medical devices and one for
Last modified: 2017-11-27 -
For researchers
An innovation entails a new or significantly improved product, service or method. It can also be a new marketing method, a new way of organizing business, work organization or external relations. The definition is developed by
Last modified: 2019-02-15 -
Sweden research country
The Swedish healthcare system In Sweden, responsibility for health and medical care is divided between the national government, regions and municipalities. The aim of the healthcare system is to achieve good health and healthcare on equal terms for
Last modified: 2019-03-12
