Testkurs für Christian

module no.: MBT-12
          course: Regulatory affairs and safety in biotechnology

                                                                     lecture | 2 SWS, 2 C

                                                                         semester MBT 12

                                                           K60 (written exam 60 min)


Dr. Thomas Brandstetter, Dr. Ralf Hess


Safety and control in biotechnology

Language of instruction:



Learning outcomes:

Students get to know the regulatory systems and safety management when dealing with biological agents.

type of instruction:



Seminar lecture with exercises


·        Biosafety and biosecurity survey

·        Biosafety level guidelines

·        Authority management

·        DIN 13485, DIN 14971 (Risk assessment), DIN 17025


reading list:

·        Satesh, M. K.: Bioethics and Biosafety, I K International Publishing House Pvt. Ltd 2008

·        Latest edition of respective laws and regulations


·        http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf

Students will be introduced in the different areas of biotechnologies. Within this for designing biodevices or executing procedures for bioanalysis, nowadays an enlarged understanding for regulatory affairs, IVD (in-vitro diagnostic) guidelines is getting mandatory. In addition to that aspects to biosafety and overall quality management has to be considered for commercial bioengineering.

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