[ 663BCELLRP23 ] Modul (*)WHO/EU Laboratory and Regulatory procedures

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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
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).
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.
Äquivalenzen (*)663BICHWHO16: Modul WHO/EU Laboratory and Regulatory procedures (3 ECTS)
Untergeordnete Studienfächer, Module und Lehrveranstaltungen