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395-0200-00L 1 Credits WBZ , NDS D-HEST

Regulatory World

Lecturers & Examiners: Prof. Dr. Jörg Goldhahn
VVZ CR n/a

Last Updated: 2026-06-03 00:07:34

Abstract

Participants will be introduced into regulations and landscape including all stake holders. The different types of medicinal products are introduced including subsequent regulations. Participants apply the knowledge in different starting scenarios.

Objective

Participants - understand the complexity of the regulatory landscape - know the main characteristics of different medicinal products and subsequent regulatory pathways - identify the different stakeholders and players in this land-scape -analyze different regulatory strategies using real-world cases

Content

• The regulatory landscape – a challenge for all players • Different types of medicinal products - different regulatory pathways • Health authorities – friend or foe? • Different countries – different regulations • Successful regulatory strategy – make or break for a medici-nal product • From idea to product – do it yourself

General Information

Language
English
Levels
WBZ , NDS
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 Regulatory World No time listed 25 h semesterly

Offered In