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Sperimentazioni cliniche

Sperimentazioni cliniche con medicamenti

BW101_10_004e_AA Guideline Clinical Trial Application Dossier (PDF, 307 kB, 23.11.2022)

FO submission form (PDF, 5 MB, 21.12.2022)

BW101_10_002e_MB FAQ on clinical trials with medicinal products (PDF, 313 kB, 01.09.2021)

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, 257 kB, 23.11.2022)

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

Sperimentazioni cliniche con trapianti / terapie genica / organismi geneticamente modificati

FO submission form (PDF, 5 MB, 21.12.2022)

I-315.AA.01-A02i Promemoria Requisiti della documentazione da fornire per le spe-rimentazioni cliniche con espianti standardizzati, te-rapia genica (TG) o con OGM (PDF, 474 kB, 31.08.2017)

I-315.AA.01-A11i Guida complementare terapia genica/dati sull’ambiente OGM (PDF, 380 kB, 26.08.2019)

I-315.AA.01-A12f Checkliste Documents pour essais cliniques Thérapie génique / OGM (PDF, 119 kB, 28.05.2019)

I-315.AA.03-A06f Formulaire Annonce d'effets indésirables TrSt / TG / OGM (DOCX, 176 kB, 24.03.2020)

I-315.AA.03-A04f Aide-mémoire: Obligation d’annoncer les effets indésirables lors d’essais cliniques avec des TrSt / TG / OGM (PDF, 169 kB, 09.04.2019)

Sperimentazioni cliniche con dispositivi medici (inclusi attrezzatura medica, impianti, strumenti, materiale di consumo, dispositivi di diagnosi, ecc.)

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

BW610_20_021e_FO Amendments, notifications, reports MD IVD (PDF, 1 MB, 01.09.2022)

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

BW610_10_021e_FO Authorisation clinical investigation MD (PDF, 1 MB, 01.09.2022)

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

BW600_00_015e_MB Clinical investigations with medical devices (PDF, 496 kB, 26.08.2022)

Guida di supporto: problemi relativi all'abilitazione dei moduli PDF

https://www.swissmedic.ch/content/swissmedic/it/home/services/documents/sperimentazioni-cliniche.html