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Development Process: Clinical
Last Updated: 2026-06-01 11:33:09
Abstract
Participants will be introduced into clinical development of medicinal products including diagnostics, medical devices, and drugs. They will learn how to develop a clinical strategy based on key characteristics of the product under development. Key considerations for supporting studies, endpoint development, and safety strategy will be discussed and applied.
Objective
Participants - understand the challenges to define a clinical development strategy - know the main elements of a clinical development plan - identify the necessary steps and stakeholders - generate a clinical development plan based on various cases
Content
• clinical strategies • GCP aspects in clinical studies • Patients as partners in development • Clinical development plan and Ph I-IV • Exploratory studies to support product development • preparation of a clinical development plan • Symposium Clinical strategy
General Information
- Language
- English
- Levels
- NDS , WBZ
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise |
Development Process: Clinical
Does not take place this semester.
|
No time listed | 17.6 h semesterly |