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Head of Quality Risk Management, FUJIFILM Diosynth Biotechnologies
This course is for you if you have an academic background with little or no knowledge of the different stages of the quality within development of a drug product.
You will gain a broad overview of connections between all stages in the development process of a drug product with focus on the GXP areas, i.e. Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice and Good Distribution Practice.
The course is relevant for you aiming to gain a basic knowledge of the law / guidelines relevant for working in a GXP environment. Also, you will be able to see the link between the different areas of work, ex. activities related to testing in animals and in humans, pharmacovigilance, manufacturing and transportation of the drug product. You will experience that some of the laws / guidelines are quite similar between the different GXP areas, but varying in the focus and the way how they are interpreted.
Course content
This course is quite unique as most lecturers work in the pharmaceutical industry. Some lecturers work in the Danish Medicines Health Authority and are focusing on the latest trends within the inspection findings.
The course will cover these topics:
Course dates
To be announced.
The course is available every second year, and will be offered next time in 2025.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Industrial Drug Development.
By attending this course you will be able to:
Professionals in need of interdisciplinary overview
The course is intended for drug development professionals who are working within drug development and manufacturing related activities, and who need basic knowledge about legislation within drug development.
You must meet the following criteria to be admitted to this course:
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
EU/EEA citizens: 12,050
Non-EU/EEA citizens: 13,825 DKK
The fee includes lunch/coffee.
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66