Quality of Medicinal Products

5 ECTS (Lectures: 45 hours, Individual project: 15 hours)

Lecturers:
Prof. Dr. S. Srčič
Prof. Dr. A. Krbavčič
Doc.Dr. L. Peterlin Mašić 
Invited experts from Pharma Industry

Syllabus outline
Survey of Slovenian and European regulatory issues and topics.
Good practices : GLP, GCP and GMP ( mainly)
SOPs
Validation procedures and qualifications
Quality assurance system
ICH
European authorisation system