The German-Polish Double-Degree Program is the only internationally cooperative Master's program in biotechnology in the state of Baden-Württemberg.



Safety and Control in Biotechnology


Bachelor's level in control engineering, knowledge in process engineering


Teaching methods Lecture
Learning target / Competences

Students have obtained comprehensive knowledge of safety and process control in bioengineering.

Duration 1
SWS 4.0
Classes 60
Individual / Group work: 60
Workload 120
ECTS 4.0
Requirements for awarding credit points

Regulatory affairs and Safety in Biotechnology: written examination, 60 minutes, weighted 50%

Process Control Engineering: written examination, 60 minutes, weighted 50%

Credits and grades



Responsible person

Professor Dr. rer. nat. Christiane Zell

Recommended semester 1
Frequency Annually (ws)

Master MBT


Regulatory Affairs and Safety in Biotechnology

Type Vorlesung
Nr. M+V2502
SWS 2.0

Students get to know the procedures and suppositions for working in the field of biotechnology, concerning regulatory affairs, biosafety and QM.

  • Biotechnology and Regulatory affairs I
  • Regulatory affairs II
  • Biosafety
  • QM in the industrial community

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.



reading list:

  • Bill Griffiths. The role of the regulatory affairs function during mergers and acquisitions. Regulatory Rapporteur. February 2011.
  • Ronan Donelan. Good decision-making practice in the regulatory arena. Regulatory Rapporteur - Vol 10, No 6, June 2013.
  • Monique Garrett. The reality of regulatory leaders in pharma today. Regulatory Rapporteur - Vol 10, No 11, November 2013.
  • Satesh, M. K.: Bioethics and Biosafety, I K International Publishing House Pvt. Ltd 2008
  • Mike Page. The regulatory affairs function as a global development strategic partner. Regulatory Rapporteur - Vol 11, No 1, January 2014.


Process Control Engineering

Type Vorlesung
Nr. M+V2503
SWS 2.0
  • the automation pyramid
  • norms and regulations
  • the most relevant DCS systems
  • sensors and actuators
  • fieldbus systems
  • controller and DCS levels
  • Schildt, H.-H.; Kastner, W.: Prozeßautomatisierung; Springer, 1998
  • Polke, M. (ed.): Process Control Engineering;VCH Weinheim 1994
  • Siemens: Manual of Siemens Simatic PCS 7, part 1 and 2

Available online: