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45395-01 - Vorlesung: Good Clinical Practice (1 KP)
| Semester | Herbstsemester 2025 |
| Angebotsmuster | Jedes Herbstsemester |
| Dozierende |
Eric Huber (eric.huber@unibas.ch, BeurteilerIn)
Elisabeth Anne Reus (elisabeth.reus@unibas.ch) Meera Saxena (meera.saxena@unibas.ch) |
| 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 |
| Teilnahmevoraussetzungen | 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 | ||
Einzeltermine
| Datum | Zeit | Raum |
|---|---|---|
| Dienstag 20.01.2026 | 08.45-17.00 Uhr | Biozentrum, Hörsaal U1.101 |
| Mittwoch 21.01.2026 | 08.45-17.00 Uhr | Biozentrum, Hörsaal U1.101 |
| Module |
Modul: Clinical Drug Development: the Basis for Market Approval (Masterstudium: Drug Sciences) |
| Prüfung | Lehrveranst.-begleitend |
| Hinweise zur Prüfung | 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 Prüfung | Anm.: Belegen Lehrveranstaltung; Abm.: stornieren |
| Wiederholungsprüfung | keine Wiederholungsprüfung |
| Skala | Pass / Fail |
| Belegen bei Nichtbestehen | beliebig wiederholbar |
| Zuständige Fakultät | Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch |
| Anbietende Organisationseinheit | Departement Pharmazeutische Wissenschaften |