542-0001-00L  Module I: Pharmacy and Legislation

SemesterAutumn Semester 2020
LecturersR. Schibli
Periodicitytwo-yearly recurring course
CourseDoes not take place this semester.
Language of instructionEnglish
CommentOnly for CAS in Radiopharmazeutischer Chemie, Radiopharmacy.

The enrolment is done by the CAS study administration.

AbstractModule 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