740868 VO Regulierung klinischer Studien, Gute klinische Praxis (Good Clinical Practice, GCP)

Sommersemester 2026 | Stand: 28.11.2025 LV auf Merkliste setzen
Institut für Pharmazie Institut für Pharmazie
Mag. (FH) Sabine Embacher-Aichhorn Mag. (FH) Sabine Embacher-Aichhorn
740868
VO Regulierung klinischer Studien, Gute klinische Praxis (Good Clinical Practice, GCP)
VO 0,5
1
Block
jährlich
Englisch

Students understand EU regulations and GCP requirements for the conduct of clinical trials

  • Historical development of the regulatory framework for clinical trials
  • Applicable regulatory requirements
  • Definitions & Responsibilities: Sponsor, Investigator, Principal Investigator, Monitor, Auditor, Inspector
  • Clinical study vs clinical trial vs non-interventional study / medicinal products vs (stoffliches) medical device / combination studies
  • Quality management (incl. vendor management, site selection, sponsor oversight)

Lecture with interactive elements involving student participation, audience response systems, online handouts

written exam

Modules 1 and 2

22.04.2024
Gruppe Anmeldefrist
01.02.2026 00:00 - 21.02.2026 23:59
Embacher-Aichhorn S.