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Abstract
An overview of the preclinical development of drugs as well as medical devices and in vitro diagnostics is given. The relevant regulations are conveyed in a practice-oriented manner.
Objective
- Understanding the principles and limitations of the preclinical efficacy and safety disciplines in product development - pharmacodynamics, pharmacokinetics and toxicology - Understanding and apply regulations for drug development, development of medical devices and in vitro diagnostics - Understanding for which purposes GLP (Good Laboratory Practice) is applied - Understanding and apply the do's and dont's of animal experiments in product development - Understanding the different possibilities and the importance of communication with the regulatory authority in early product development
Content
The Module 4 "Development Process: Preclinical" includes an overview of preclinical efficacy and safety in drug development as well as in the development of medical devices and in vitro diagnostics. Emphasis will be placed on the applicable regulations and potential interactions with regulatory authorities in early product development. When a preclinical development plan becomes necessary and what is needed to start with will be explained in a practical way. An overview is also given of which preclinical studies and documents are required in order to be able to conduct an early clinical study in humans for the first time.
General Information
- Language
- English
- Levels
- WBZ , NDS
- Frequency
- Yearly recurring
Examination
- Type
- ungraded semester performance
Registration & Places
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture with exercise | Development Process: Preclinical | No time listed | 51 h semesterly |