Admission Requirements
Students have finished the first year of their master program, including their first internship and mandatory courses. Students from the following master programs can participate in the course: Biomedical Sciences, Biopharmaceutical Sciences, Biology, Life science & Technology, and Chemistry.
Description
The development of new therapeutic drugs is extremely challenging. The majority of drugs fail clinical trials and never reach the market. Cell-based therapies bring in novel challenges, such as the selection of the type of donor cells (autologous or not), delivery to the diseased organ, reliable production and proper quality control from production to delivery to the patient. It is, therefore, very important to improve the succes of the drug discovery pipeline, cut the cost, and speed up the process of developing new drugs.
Whether you're studying Bio-Pharmaceutical Sciences (BPS), Biomedical Sciences (BMS), Biology, Chemistry, or Life Science & Technology (LST), this course provides essential insights into the quality management and control - a field in which the pharmaceutical industry has a growing need for professionals with expertise in the development and production of drugs and vaccines. This course is organized in collaboration with the master Biopharmaceutical Sciences, the Biotech training Facility (BTF) and ReNew, the international consortium which aims to bring stemcell based therapies from the lab to the patient.
Course objectives
After the course, students will have:
Knowledge of the principles of 'quality by design' and the GMP requirements at the various stages of product development (research, animal studies, clinical phase I, II & III);
Understanding of the importance of Regulations, Quality Management Systems, and GMP as prerequisites for production, quality and safety management, and batch release of medicinal products;
Understanding of pharmaceutical microbiology and the purpose of the different contamination control mechanisms as well as the impact if they do not function properly;
Experience with common production steps in biopharmaceutical GMP manufacturing, in aseptic manufacturing, and in working in a clean room;
Understanding of manufacturing biopharmaceutical and cell-based medicinal products, such as Advanced Therapy Medicinal Products (ATMPs) and vaccines.
Timetable
Will be provided in the Brightspace module of the course.
Mode of instruction
Lectures, self-study assignments, work groups, practicals.
Assessment method
Mandatory presence, finishing e-learings and final assignment Pass/ no pass.
Reading list
Will be distributed during the course
Registration
Registration takes place via announcements on brighspace and a mailing is sent out in the beginning of June to participating programs.
Contact
For Faculty of Science students:
Study planning: Visit on of the study advisor walk-in hours
Course content: directorBPS@lacdr.leidenuniv.nl
For BMS students: masterBMC@lumc.nl