Inhalt
[ 663BCELLRP23 ] Module WHO/EU Laboratory and Regulatory procedures
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Mode of examination |
Education level |
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Responsible person |
Coordinating university |
| 3 ECTS |
Accumulative module examination |
B - Bachelor's programme |
(*)Biologische Chemie |
Alexandr Jegorov |
USB Budweis |
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| Detailed information |
| Original study plan |
Bachelor's programme Biological Chemistry 2023W |
| Objectives |
In this unique, industry practice-oriented course, students learn laboratory and legal procedures commonly performed by industrial laboratory/research supervisors. The requirements and WHO/EU regulations for registration, testing and authorized analysis of drugs, (bio)chemical products, dietary supplements, food, etc. are given. An important part of this course is a description of practical experience from the laboratories - how to prepare a sample, how to interpret the data etc.
We recommend this course to everybody who is planning her/his carrier in the chemical, biotechnological, or pharmaceutical industry or the pharmaceutical (including production or development).
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| Further information |
Contents of lectures:
1.Basic definition of products (food, dietary supplements, chemicals, API´s, drugs, etc.).
2.Relevant part of EC, WHO, FAO, FDA, national authority, ets., guidelines, and their mutual relationship. Tracing of a selected example.
3.Registration of products.
4.Test methods - a state of art. Qualitative and quantitative aspects.
5.Review of instrumental methods; principle, availability, cost, and information value.
6.Validation of analytical methods.
7.Testing of biological activity. Ethical guidelines, laboratory screening, models, and approved methods.
8.Origin and importance of impurities. Case examples. Qualification of impurities.
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| Corresponding lecture |
663BICHWHO16: Modul WHO/EU Laboratory and Regulatory procedures (3 ECTS)
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