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| Semester | Herbstsemester 2024 |
| Angebotsmuster | Jedes Herbstsemester |
| Dozierende | Christian Burri (christian.burri@unibas.ch, BeurteilerIn) |
| Inhalt | Compact two day introductory course to the Good Clinical Practice guideline (GCP) designed according to the requirements of Swissethics (level of investigators and sub-investigators). The course provides a compact insight into the ICH E6 GCP regulation and related topics. It is ideal for Investigators, study personnel and people involved and/or interested in clinical research. It serves as beginners as well as refresher training. Content: Principles of the ICH-GCP guideline and its historical background; Legal and regulatory requirements of clinical research; Role of ethics committees and regulatory authorities; Quality and data management in clinical trials; Study documentation, incl. structure and content of study protocol; Study design and basic statistical principles; Outlook to upcoming new regulations |
| Lernziele | Understanding the basic principles of research involving humans Knowing the fundamental principles of Good Clinical Practice |
| Literatur | Mandatory reading Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Version 2012 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/) - detailed pre-reading required Guideline ICH E8(R1) General considerations for clinical studies (https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guideline) - detailed pre-reading required Guideline ICH E6(R2) Good Clinical Practice (https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice) - familiarizing is of an advantage |
| Bemerkungen | Pre-registration is mandatory. A certificate of participation will be handed out Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
| Weblink | Department of Pharmaceutical Sciences |
| Teilnahmebedingungen | Pre-registration by writing an email to studienkoordination-pharma@unibas.ch is mandatory. Enrolled student at the Department of Pharmaceutical Sciences. |
| Anmeldung zur Lehrveranstaltung | Due to a limited number of seats a pre-registration by writing an email to studienkoordination-pharma@unibas.ch is mandatory. |
| Unterrichtssprache | Englisch |
| Einsatz digitaler Medien | kein spezifischer Einsatz |
| Intervall | Wochentag | Zeit | Raum |
|---|---|---|---|
| täglich | Siehe Einzeltermine | ||
| Datum | Zeit | Raum |
|---|---|---|
| Mittwoch 22.01.2025 | 08.45-12.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Mittwoch 22.01.2025 | 13.00-17.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Donnerstag 23.01.2025 | 09.00-12.30 Uhr | Pharmazentrum, Hörsaal 2 |
| Donnerstag 23.01.2025 | 13.30-16.00 Uhr | Pharmazentrum, Hörsaal 2 |
| Module |
Modul: Clinical Drug Development: the Basis for Market Approval (Masterstudium: Drug Sciences) |
| Leistungsüberprüfung | Lehrveranst.-begleitend |
| Hinweise zur Leistungsüberprüfung | Complete participation and 70% correct answers in the Multiple choice test (self-checking of acquired knowledge) at the end of the seminar |
| An-/Abmeldung zur Leistungsüberprüfung | Anm.: Belegen Lehrveranstaltung; Abm.: stornieren |
| Wiederholungsprüfung | keine Wiederholungsprüfung |
| Skala | Pass / Fail |
| Wiederholtes Belegen | beliebig wiederholbar |
| Zuständige Fakultät | Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch |
| Anbietende Organisationseinheit | Departement Pharmazeutische Wissenschaften |