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  1. Restrictions in IGJ on-site inspections due to safety risks

    During national or international crises, on-site GxP inspections may not be possible for a number of reasons such as travel ...

    Publication | 20-09-2022

  2. GLP domestic test facilities

    Publication | 16-03-2022

  3. GLP: Non-domestic test facilities

    Publication | 16-03-2022

  4. IGJ assessment framework: Deployment of eHealth by healthcare providers

    The assessment framework in this booklet is the starting point for supervision by the Dutch Health and Youth Care Inspectorate ...

    Publication | 25-11-2021

  5. FAQ about inducements (Medical Devices Act)

    Report | 28-05-2021

  6. Guidance on the Management of Clinical Trial during the COVID-19 (Coronavirus) pandemic

    Due to the corona crisis the source data verification for the majority of the clinical trials conducted is severely hampered. ...

    Publication | 23-02-2021

  7. A: Relevant legislation

    Publication | 01-10-2020

  8. B: Clinical investigations involving the use of medical devices – regime

    Publication | 01-10-2020

  9. Requirements (re)start clinical trials

    Report | 25-08-2020

  10. Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)

    Publication | 25-08-2020

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