Inhalt
[ 663BCELLRP23 ] Module WHO/EU Laboratory and Regulatory procedures
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| Workload |
Mode of examination |
Education level |
Study areas |
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 2025W |
| Learning Outcomes |
Competences |
| 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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| Skills |
Knowledge |
| Students will know and understand regulations in the pharmaceutical and chemical industry and research laboratories (k1, k2), will be able to apply this knowledge in practical life in the laboratory (k3), and develop procedures to meet the regulations (k6).
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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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| 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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| Subordinated subjects, modules and lectures |
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