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395-0205-00L 3 Credits NDS , WBZ D-HEST
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Development Process: Clinical

Lecturers & Examiners: Prof. Dr. Jörg Goldhahn, Dr. Markus Kalousek, Ivo Schauwecker
VVZ CR n/a

Last Updated: 2026-02-05 16:37:05

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

Priority: Registration for the course unit is only possible for the primary target group

Course Components

Type Title Time & Place Hours
lecture with exercise Development Process: Clinical
  • 22.03 Date 09:15-17:00 (CHN G 46)
  • 05.04 Date 09:00-17:00 (ON LI NE)
  • 12.04 Date 09:15-17:00 (CHN G 46)
  • 19.04 Date 09:15-17:00 (CHN G 46)
  • 26.04 Date 09:00-17:00 (ON LI NE)
  • 03.05 Date 09:00-17:00 (ON LI NE)
  • 17.05 Date 09:15-17:00 (CHN G 46)
17.6 h semesterly

Offered In