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541-0007-00L 2.5 Credits WBZ D-CHAB
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Module 7: Clinical Development

Lecturers: Prof. Dr. Roger Schibli, Regula Furegati Hafner
Examiners: Regula Furegati Hafner
Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration.
VVZ CR n/a

Last Updated: 2026-02-05 16:15:17

Abstract

Module 7 gives an overview about the several steps that have to be followed during the process of clinical development.

Objective

• Preclinical bridge to clinical development • Strategy for clinical development • Regulatory aspects of clinical development • Good clinical practice (GCP) and quality assurance • First in human studies (Phase I), Proof of concept studies (Phase II), Registration studies (Phase III), Post-registration studies (Phase IV) • Monitoring • Organizational and financial aspects of clinical development • Portfolio and life cycle management • Data management and simulation of a clinical study • Personalized medicine

General Information

Language
English
Levels
WBZ
Frequency
Every two years

Examination

Type
ungraded semester performance

Course Components

Type Title Time & Place Hours
lecture with exercise Module 7: Clinical Development
Block course
  • 26.09. - 28.09 Date 08:45-17:30 (HIT E 51)
  • 03.10. - 04.10 Date 08:45-17:30 (HIT E 51)
40 h semesterly

Offered In