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Quality Management in Pharma and Biotech. Module 1 - The Role of the Qualified Person


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 GMP voor het Middenkader must be completed.


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.


This course is offered by PCS and starts in April 2024, continuing in May. The module consist of four training days. (Block A on 9 & 10 April, Block B on 14, 15 & 16 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.


Enrollment via My StudyMap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).


Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen,


This course is only available for students of the Industrial Pharmacy specialisation.

This information is without prejudice. Alterations can be made for next year.