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  1. File/document Specific rules for medicines

    Specific rules for medicines A trial protocol is required for the application to the Medical Products Agency Allocating roles and responsibilities in accordance with Good Clinical Practice Set up systems for data collection, data processing and data

    Last modified: 2022-01-03 14.37

  2. File/document Specific rules for medical devices

    Specific rules for medical devices Design of a medical device study Medical device aspects on ethical review Should the study be reviewed by the Swedish Medical Products Agency? Medical device studies abroad An adapted clinical investigation plan is

    Last modified: 2021-09-01 17.07

  3. File/document Application

    Application It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the

    Last modified: 2022-01-03 15.14

  4. File/document Specific rules for medicines

    Specific rules for medicines Applying for authorisation for a medicine study Visa mer Visa mindre Applying for authorisation for a medicine study The purpose of clinical studies involving the investigation of a new medicine may be to discover or

    Last modified: 2022-01-03 14.44

  5. File/document Specific rules for medical devices

    Specific rules for medical devices Notification and application to the Swedish Medical Products Agency Visa mer Visa mindre New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021. Notification and

    Last modified: 2022-01-03 14.48

  6. File/document Execution

    Execution Once the approvals required for your clinical study have been obtained, the practical work on the study can start. Page contents: Page contents: Study participants need to give written consent Collecting and managing study data What applies

    Last modified: 2021-09-03 11.14

  7. File/document Specific rules for medicines

    Specific rules for medicines Producing trial files Implementing monitoring Reporting side effects Ensuring that all data are complete and correct Summarising an annual safety report Reporting that the study is completed Visa mer Visa mindre Producing

    Last modified: 2020-07-06 11.12

  8. File/document Specific rules for medical devices

    Specific rules for medical devices Medical device perspectives on consent from study participants Summarise documentation in study folders Initiation visit Handling of medical devices in clinical investigation Safety reporting of device deficiencies

    Last modified: 2021-09-01 17.08

  9. File/document Analysis

    Analysis It is a good idea to consult a statistician already during the planning phase to enable the production of correctly analysed data and publication of the result. Early preparation is crucial for producing a good study design, the correct

    Last modified: 2021-07-08 16.50

  10. File/document Specific rules for medical devices

    Specific rules for medical devices Medical device with a therapeutic purpose Medical device with a diagnostic purpose Visa mer Visa mindre New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021. The

    Last modified: 2021-09-01 17.08

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  1. / English / News / More efficient decision-making path for medicine studies

    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
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