Sperimentazioni cliniche

BW101_10_004e_AA Guideline Clinical Trial Application Dossier (PDF, 877 kB, 12.05.2023)

FO submission form (PDF, 5 MB, 17.11.2023)

BW101_10_002e_MB FAQ on clinical trials with medicinal products (PDF, 751 kB, 11.05.2023)

BW101_10_006e_AA Guidance Pharmaceutical Quality Dossier (PDF, 296 kB, 01.04.2015)

BW101_10_018f_FO Essais cliniques de catégorie B faisant intervenir des Médicaments susceptibles d’émettre des rayonnements ionisants (DOCX, 95 kB, 20.12.2018)

BW101_10_003e_AA Guideline Amendments Clinical Trials (PDF, 517 kB, 12.05.2023)

BW101_20_002e_MB Safety of Medicines (PDF, 194 kB, 13.09.2022)

FO submission form (PDF, 5 MB, 17.11.2023)

BW315_00_980i_MB Promemoria Requisiti della documentazione da fornire per le sperimentazioni cliniche con espianti standardizzati TG/OGM (PDF, 2 MB, 28.04.2023)

BW315_00_972i_WL Guida complementare terapia genica/dati sull’ambiente OGM (PDF, 2 MB, 28.04.2023)

BW315_00_971f_CL Liste de contrôle pour essais cliniques avec des TrSt/TG/OGM (PDF, 267 kB, 28.04.2023)

BW315_00_960i_FO Formulario Notifica eventi indesiderati Sclin ATMP (DOCX, 374 kB, 15.02.2024)

BW315_00_961i_MB Scheda informativa Obblighi di notifica per eventi indesiderati durante una sperimentazione clinica con ATMP e altri prodotti (batteriofagi ecc.) e procedimenti (PDF, 358 kB, 15.02.2024)

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 775 kB, 27.12.2023)

BW600_00_016e_MB Performance studies with IVD (PDF, 745 kB, 27.12.2023)

BW610_10_021e_FO Authorisation clinical investigation MD (PDF, 1 MB, 01.11.2023)

BW610_10_022e_FO Clinical trials of research sequences on CE-marked MRI systems (PDF, 1 MB, 01.09.2022)

BW610_10_023e_FO Application simplified review MD (PDF, 1 MB, 01.10.2023)

BW610_10_024e_FO Authorisation performance study IVD (PDF, 1 MB, 01.11.2023)

BW610_10_025e_FO Application simplified review IVD (PDF, 1 MB, 01.10.2023)

BW610_20_021e_FO Amendments, notifications, reports MD IVD (PDF, 1 MB, 01.11.2023)

BW610_20_022e_FO Notification of safety measures MD IVD (PDF, 1 MB, 01.09.2022)

BW610_20_023e_FO SAE-CH and DD-CH MD (PDF, 1 MB, 01.09.2022)

BW610_20_024e_FO SAE-CH and DD-CH IVD (PDF, 1 MB, 30.09.2022)