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34746-01 - Lecture: Regulatory Analysis of Pharmaceuticals and Medical Devices: Legal, Political and Economic Perspectives 3 CP

Semester spring semester 2018
Course frequency Irregular
Lecturers Catherine Sharkey (, Assessor)
Content Course Description:
The regulation of pharmaceuticals and medical devices - fields of rapid technological growth and innovation - is a topic of legal, economic, and policy significance. Our study of regulation will encompass an exploration of such direct controls as governmental legislation and agency directives and indirect controls like products liability litigation, insurance, intellectual property, and antitrust regimes. We will study how technological advances in the pharmaceutical and medical device industry
challenge and demand redefinition of the institutional relationships between agencies and courts , and of the mechanisms of supervision and control provided by the market, government, and common law litigation.

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Admission requirements Solid understanding of business and economics on the BA level
Completion of an introductory course in law (BA) would be helpful
Health Economics (Gesundheitsökonomie, 27707)
Advanced Public Economics: Behavioral Models and Applications (43497)
Course application Course application:
All applications have to be processed through the Summer School office. Please fill in the application form, which can be found on the weblink:

There is an orientation for all Summer School courses on Thursday 1 March, 2018; 17:00 at the WWZ, Auditorium.
The online application is open from 2 March until 26 March 2018. Applications that are submitted by 12 March (23:59) will be handled on a priority basis.
For more information please visit the Summer School website:
The enrollment for the lecture is at the same time the application for the exam!
If there are still vacancies, we will accept late applications until 31 May 2018.

Language of instruction English
Use of digital media No specific media used


Interval Weekday Time Room

No dates available. Please contact the lecturer.

Modules Module: Electives (Master Business and Economics)
Specialization Module: Global Life Sciences and Sustainability (Master Business Law)
Specialization module: Life Sciences Law (Master Law)
Specialization module: Transnational Law (Master Law)
Assessment format end-of-semester examination
Assessment details Course Requirements/Grades:
Final grades will be determined by class participation (25%) and 24 hour take - home final examination (75%)
24-hour take-home final exam (due on 13 July 2018)
Assessment registration/deregistration Registration/deregistration: faculty
Repeat examination no repeat examination
Scale 1-6 0,1
Repeated registration as often as necessary
Responsible faculty Faculty of Business and Economics ,
Offered by Faculty of Business and Economics