Sperimentazioni cliniche

BW101_10_004e_AA Guideline Clinical Trial Application Dossier (PDF, 336 kB, 17.01.2020)

BW101_10_001e_FO Application Form for clinical trials on medicinal products / transplant products / gene therapy / GMO (PDF, 1 MB, 04.04.2018)

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_00_001e_FO Administrative changes (incl. sponsorship and Swiss rep.) (PDF, 1 MB, 22.10.2019)

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, 233 kB, 19.06.2022)

BW101_10_004e_FO Submission of Changes to a Clinical Trial and Answer to Conditions (DOCX, 176 kB, 10.04.2019)

BW101_20_002e_FO Reporting Related to a Clinical Trial (DOCX, 175 kB, 10.04.2019)

BW101_20_001i_FO Formulario di accompagnamento SUSAR (DOCX, 161 kB, 21.11.2019)

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

BW101_10_001e_FO Application Form for clinical trials on medicinal products / transplant products / gene therapy / GMO (PDF, 1 MB, 04.04.2018)

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)

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)