EXPORT-ORIENTED MANAGEMENT - IMC Fachhochschule Krems

Teaching Concept
Presentation lead by the lector, motivation/integration of the audience by questions
Evaluation
Final exam
GLP and GMP regulations
Semester Hours per week Subject code ECTS
Spring 1 GMP_T II 2
Learning Outcomes/Course objectives
GLP/ GMP is a one hour credit course, designed to teach an clear understanding on the
regulation governing the field of pharmaceutical quality management. The course should
provide the students with a
� Overview on regulation applicable to non-clinical drug development
� Overview on regulations governing pharmaceutical production
� Overview on standards and regulations governing pharmaceutical quality
management
Prerequisites/ Level
Advanced
Course Description
The lecturer will give an overview on non-clinical development and quality management
in the pharmaceutical industry. The students will subsequently present central regulatory
documents in the field of preclinical development, clinical development, pharmaceutical
manufacturing and Quality management.
Teaching Concept
The study subject will be taught according to general OECD / WHO /EU and local
directives and local guide lines. Students will be provided with power point presentations
and supplemental material as appropriate.
Groups of 2-3 students will then present regulatory guide lines to one of 12 different
topics (~20 min presentation 5 min discussion) to deepen their understanding on how
legislation is implemented.
Evaluation
Final exam
IT: Databases
Semester Hours per week Subject code ECTS
Spring 1 IT III 2
Learning Outcomes/Course objectives
The students are able to talk about databases with IT experts and programmers, to
articulate what they are in need of. The students have managed to build their own small
queries to get selected data for analysis. Students can extract data from databases for
additional analysis in excel and know how to analyze data in excel to achieve a good
result.
Prerequisites/ Level
Advanced
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