Inhalt
[ 663BCELLRP23 ] Modul (*)WHO/EU Laboratory and Regulatory procedures
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| (*) Leider ist diese Information in Deutsch nicht verfügbar. |
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| Workload |
Form der Prüfung |
Ausbildungslevel |
Studienfachbereich |
VerantwortlicheR |
Anbietende Uni |
| 3 ECTS |
Kumulative Modulprüfung |
B - Bachelor |
Biologische Chemie |
Alexandr Jegorov |
USB Budweis |
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| Detailinformationen |
| Quellcurriculum |
Bachelorstudium Biological Chemistry 2023W |
| Ziele |
(*)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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| Sonstige Informationen |
(*)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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| Äquivalenzen |
(*)663BICHWHO16: Modul WHO/EU Laboratory and Regulatory procedures (3 ECTS)
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| Untergeordnete Studienfächer, Module und Lehrveranstaltungen |
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