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542-0001-00L 4 Credits WBZ D-CHAB
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Module I: Pharmacy and Legislation

Lecturers: Prof. Dr. Roger Schibli
Examiners: Prof. Dr. Roger Schibli, Regula Furegati Hafner
Does not take place this semester. Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy. The enrolment is done by the CAS study administration.
VVZ CR n/a

Last Updated: 2026-02-05 15:35:35

Abstract

Module I:Knowledge of the fundamentals of development, preparation, testing and stability of sterile radiopharmaceutical preparations.Acquirement of basic information on European legislation in Radiopharmacy including GMP and Pharmacopoeia.Understanding basics of gene engineering and pharmacokinetics

Objective

• Good manufacturing practice (GMP) of classical radiopharmaceuticals • GMP: industrial point of view • Molecular and cellular aspects of radiobiology • Pharmacopoeia • Pharmacopoeia – how to use it • Design of dosage forms for pharmaceuticals • Pharmaceutical packaging • Methods of preparation of sterile products • Aseptic preparation • The role of excipients in parenteral radiopharmaceutical preparations • Sterility testing and endotoxin determination • Particulate contamination • Principles of medicinal chemistry • An overview of modern pharmaceutical analysis • Genetic engineering • Stability and shelf-life of pharmaceuticals • (in)stability of radiopharmaceuticals • Legislation in radiopharmacy • European directives – GMP • Specific radiopharmaceutical legislation • Clinical trials directive and related documents • The small scale, non-commercial preparation of radiopharmaceuticals • GMP of PET radiopharmaceuticals • Quality assurance and preparation of SOP • Water for pharmaceutical use • Practicals: visit to hospital radiopharmacy • Basic concepts of pharmacokinetics • Drug regulatory affairs • Microbiology in Pharmacy • Visit to pharmaceutical company

General Information

Language
English
Levels
WBZ
Frequency
Every two years

Examination

Type
ungraded semester performance

Course Components

Type Title Time & Place Hours
lecture with exercise Module I: Pharmacy and Legislation
Does not take place this semester. Block course, takes place in Slovenia, University of Ljubljana
No time listed 80 h semesterly

Offered In