7 documenten
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Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified by means of viral vectors v5 1694786673 Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified by means of viral vectors v5PDF | 471,66 kB
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Common Application form for clinical research with human cells genetically modified by means of viral vectors v5 1694786544 Common Application form for clinical research with human cells genetically modified by means of viral vectors v5DOCX | 30,30 kB
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2020-07-23 Guidance document viral vectors - Netherlands_V2.1 1575971102 2020-07-23 Guidance document viral vectors - Netherlands_V2.1PDF | 311,38 kB
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2020-07-23 Guidance document AAV vectors - Netherlands _V1.1 1575971026 2020-07-23 Guidance document AAV vectors - Netherlands _V1.1PDF | 281,42 kB
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Common application form for viral vectors contained in investigational medicinal products for human use 1572609944 Common application form for viral vectors contained in investigational medicinal products for human useDOCX | 43,58 kB
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Good Practice on the assessment of GMO related aspects in the context of clinical trials with AAV clinical vectors 1572609662 Good Practice on the assessment of GMO related aspects in the context of clinical trials with AAV clinical vectorsPDF | 360,96 kB
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Common application form for investigational medicinal products for human use that contain or consist of AAV vectors 1572609557 Common application form for investigational medicinal products for human use that contain or consist of AAV vectorsDOCX | 36,54 kB