Documents - Medicines
7 documents on Medicines
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GLP domestic test facilities
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GLP: Non-domestic test facilities
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Template for Risk-Assessment Questionnaire Pharmacovigilance
This template is to help marketing authorization holders (MAHs) during the collection of information from different departments ...
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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 ...
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Requirements (re)start clinical trials
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Coronavirus (COVID-19): impact on the conduct of clinical trials under the Medical Research Involving Human Subjects Act (WMO)
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FAQ risk-based pharmacovigilance questionnaire
In order to effectively monitor the compliance of Dutch MAHs’ with the Dutch and EU legislation, the Inspectorate has developed a ...