Documenten | Loket Gentherapie

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 15-09-2023 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 PDF | 471.66 kB
Common Application form for clinical research with human cells genetically modified by means of viral vectors v5 15-09-2023 Common Application form for clinical research with human cells genetically modified by means of viral vectors v5 DOCX | 30.3 kB
Voorbeelden meldingscategorieën Rggo art35c 12-01-2023 Voorbeelden meldingscategorieën Rggo art35c PDF | 110.63 kB
Wijziging Regeling ggo 2013 tav meldingen klinische studies 12-01-2023 Wijziging Regeling ggo 2013 tav meldingen klinische studies PDF | 1.47 MB
01-2023 Formulier VVW v1.0 11-01-2023 01-2023 Formulier VVW v1.0 DOCX | 33.16 kB
01-2023 Formulier BVW v1.0 11-01-2023 01-2023 Formulier BVW v1.0 DOCX | 31.6 kB
Gestandaardiseerde MRB VOV gm cellen AAV (art39d) 11-01-2023 Gestandaardiseerde MRB VOV gm cellen AAV (art39d) PDF | 598.01 kB
10-2021 Guidance document VOV art 39d gm-cells AAV 11-01-2023 10-2021 Guidance document VOV art 39d gm-cells AAV DOCX | 34.92 kB
application form VOV gm cells_art39d_2022-12 v1.1_EN 11-01-2023 application form VOV gm cells_art39d_2022-12 v1.1_EN DOCX | 44.78 kB
application form VOV gm cells_art39c_2022-12 v1.1_EN 11-01-2023 application form VOV gm cells_art39c_2022-12 v1.1_EN DOCX | 45.98 kB