EXPORT-ORIENTED MANAGEMENT - IMC Fachhochschule Krems

Clinical Studies and GCP
Semester Hours per week Subject code ECTS
Spring 1 GCP I 2
Learning Outcomes / Course Objectives
After this course students know about the basic principles of GCP and its background and
historical development. Furthermore they know the main laws, regulations, roles and
responsibilities applicable for the conduct of clinical trials. The course gives insights into
the phases of the clinical development of medicinal drugs and the current strategies of
drug development.
Prerequisites / Level
None
Course Description
On the basis of GCP the students will gain an overview on the different phases (I-IV) of
the clinical development process. The set-up, directing and the monitoring of different
clinical studies will be discussed. A special focus lies herby on the project management of
clinical studies and the responsibilities of a clinical monitor. For the better understanding
of the teaching the student will get problems to solve which can come up during clinical
studies. These problems will then be identified and solved in small groups.
Teaching Methods
Face to face sessions with interactions (question/answer) between student and lecturer,
brain-storming exercises in small groups with oral presentation to the whole group.
Evaluation
Final exam
Material Science and Biomaterials
Semester Hours per week Subject code ECTS
Spring 1 MSC 2
Learning Outcomes / Course Objectives
This course gives an outline on the basics of material science including specific details on
biomaterials.
Prerequisites / Level
None
Course Description
The students should get an overview on the basic requirements of equipment materials,
material selection for facilities and facility parts. Biocompatibility of materials, metals and
plastics and their use in process technology are also dealt with in this course.
Teaching Methods
The content will be worked out in a mixture of basic lessons, specialised lessons, highlevel
discussion and work in groups.
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