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Legislation of Production of Medicinal Products

Vak 2019-2020

Description

This course on Good Manufacturing Practice (GMP) guidelines and Legislation is based on case studies that discussed under supervision of a qualified specialist in these subjects. Prior to the course students are expected to compare Eudralex en de Geneesmiddelenwet (Medicines Act). Special attention will be given to falsified medicines.

Coordinator

Studyadviser: studyadvisorBPS@lacdr.leidenuniv.nl

Admission requirements

Restricted to Master’s Students of Bio-Pharmaceutical Sciences, specialisation Industrial Pharmacy.

Mode of instruction

Self study, case studies and discussions.

Course objectives

To learn to read and to understand the Geneesmiddelenwet (Medicines Act) in combination with Eudralex.

Assessment method

Participation and the level and quality of the contributions to the discussions.

Timetable

The course will be organised on request in concert with the participants and the teacher.

Registration

Contact the study advisers of BPS.