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45395-01 - Vorlesung: Good Clinical Practice 1 KP

Semester Herbstsemester 2022
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.
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 2015 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/)
Optional reading: Guideline ICH E6 Good Clinical Practice (https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice)
Bemerkungen 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 Preregistration at studienkoordination-pharma@unibas.ch
Anmeldung zur Lehrveranstaltung THE SEMINAR IS FULLY BOOKED - please contact studienkoordination-pharma@unibas.ch
Unterrichtssprache Englisch
Einsatz digitaler Medien kein spezifischer Einsatz


Intervall wöchentlich
Datum 17.01.2023 – 18.01.2023
Zeit Dienstag, 08.00-17.00 Biozentrum, Hörsaal U1.101
Datum Zeit Raum
Dienstag 17.01.2023 08.00-17.00 Uhr Biozentrum, Hörsaal U1.101
Mittwoch 18.01.2023 08.00-17.00 Uhr Biozentrum, Hörsaal U1.101
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 at the Multiple choice test (self-checking of acquired knowledge) at the end of the seminar
An-/Abmeldung zur Leistungsüberprüfung An-/Abmelden: Belegen resp. Stornieren der Belegung via MOnA
Wiederholungsprüfung keine Wiederholungsprüfung
Skala Pass / Fail
Wiederholtes Belegen beliebig wiederholbar
Zuständige Fakultät Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch
Anbietende Organisationseinheit Departement Pharmazeutische Wissenschaften