Admission requirements
Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report and Oral presentation. Only available to students of the Industrial Pharmacy specialisation. The course Good Manufacturing Practice (GMP) for Middle Management must be completed.
Description
This training provides insight into an integrated approach on quality management as a good business practice in the pharmaceutical and biotechnological industries and hospitals to safeguard the quality of their products. There will be a focus on the role and responsibilities of the Qualified Person (QP) as well as on legislation, guidelines and best practices.
It also discusses common challenges a QP encounters in the day-to-day activities. The student will participate in a team to work out a case study in the period between the first and second training sessions.
Course objectives
After completion of this course students has knowledge about:
Basic principles of quality management for the pharmaceutical industry from a regulatory and business perspective.
Applicable GMP regulations and expectations across the product life cycle.
Specific regulatory responsibilities of Senior Management, functional leaders, the Qualified Person and the Responsible Person.
Current regulatory developments and their business impact, e.g., new regulations, the Falsified Medicines Directive (serialization).
Issues that may impact the business (drug shortages and supply chain integrity).
The impact of behavior and culture.
Timetable
This course is offered by PCS and starts in April 2024, continuing in May. The module consist of five training days. (Block A on 8 & 9 April, Block B on 13, 14 & 15 May in Van Der Valk Breukelen).
Mode of instruction
Lectures, self-tuition, discussion, case study.
Assessment method
This course will be concluded by a written exam (part multiple choice and open questions) and an assignment. The multiple choice exam counts for 20% and the written exam and assignment each count for 40% of the final grade.
For each individual exam, the grade is expressed by using a decimal integer between 1.0 and 10.0 that should be ≥ 5.5. The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0.
The final grade should be 5.5 to successfully complete this course.
Reading list
Will be announced during the course.
Registration
Enrollment via MyStudymap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).
Contact
Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen, studyadvisorBPS@lacdr.leidenuniv.nl.
Remarks
This course is only available for students of the Industrial Pharmacy specialisation.
This information is without prejudice. Alterations can be made for next year.
Software
Starting from the 2024/2025 academic year, the Faculty of Science will use the software distribution platform Academic Software. Through this platform, you can access the software needed for specific courses in your studies. For some software, your laptop must meet certain system requirements, which will be specified with the software. It is important to install the software before the start of the course. More information about the laptop requirements can be found on the student website.