Vanwege de coronamaatregelen kan de onderwijsvorm of tentaminering afwijken. Zie voor actuele informatie de betreffende cursuspagina’s op Brightspace.

Studiegids

nl en

Legislation of Production of Medicinal Products

Vak
2020-2021

Admission requirements

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

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.

Course objectives

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

Timetable

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

Mode of instruction

Self study, case studies and discussions.

Assessment method

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

Reading list

Registration

Contact the study advisers of BPS.

Contact

Studyadviser: studyadvisorBPS@lacdr.leidenuniv.nl

Remarks

NA