[ 663BCELLRP23 ] Module WHO/EU Laboratory and Regulatory procedures

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
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).
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.
Corresponding lecture 663BICHWHO16: Modul WHO/EU Laboratory and Regulatory procedures (3 ECTS)
Subordinated subjects, modules and lectures