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Biotechnology has become an important aspect of pharmaceutical research and development. A number of biotechnology-derived pharmaceuticals have been introduced into the market in the recent past. In addition, biotechnology delivers essential tools for drug discovery. Therefore, it is essential to understand the potential and the limitation of biotechnology for the pharmaceutical industry.
Objectives: To enhance the student’s understanding of the impact of modern biotechnology on therapeutical possibilities and ethics. To be aware of the specific regulations and registration requirements concerning clinical trials with biological, biotechnological and gentechnological active substances. To explain the relevance of modern biotechnology to people, health system and markets.
Topics: Introduction to biotechnology, specific regulations concerning clinical trials and registration, newest developments.
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