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45395-01 - Vorlesung: Good Clinical Practice 1 KP

Semester Frühjahrsemester 2024
Angebotsmuster unregelmässig
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.

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/) - 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 Please note the exceptional lecture times !
Wed 5 June: 08:45 - 12:00 / 13:00 - 17:00
Thu 6 June: 09:00 - 12:30 / 13:30 - 16:00

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
Block Siehe Einzeltermine
Block Siehe Einzeltermine


Datum Zeit Raum
Mittwoch 05.06.2024 08.45-17.00 Uhr Pharmazentrum, Hörsaal 1
Donnerstag 06.06.2024 09.00-16.00 Uhr Pharmazentrum, Hörsaal 1
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