5 ECTS credits
150 h study time
Offer 1 with catalog number 4023430DNR for all students in the 1st semester at a (D) Master - preliminary level.
This practical course is given under the form of project teaching. The students are divided in groups and each group is assigned to set up a file in order to check the quality of a drug product. This is done according to the applicable European guidelines. The students themselves are required to develop, validate and apply procedures for the quality control of a drug product. This can be done by using the knowledge acquired during previous practical classes (e.g. Pharmaceutical Analysis practical class and Instrumental Pharmaceutical Analysis practical class) and lectures, but also by consulting the available literature (Pub-Med, Web of Science, books that can be consulted via MedicinesComplete,...).
There are also a number of online lesson recordings and webinars available to explore certain aspects in greater depth.
Not applicable
- The student has insight into the quality aspects of medicines.
- The student has knowledge of the applicable standards and guidelines regarding quality requirements of medicines when applying for a marketing authorization.
- The student can apply the different analytical techniques discussed in the theoretical courses Pharmaceutical Analysis, Instrumental Pharmaceutical Analysis and Applications of Instrumental Analysis in a given context.
- The student knows the techniques and instruments currently used for pharmaceutical quality control and can critically compare them. He/she can select the appropriate technique for the intended application.
- The student can independently plan, conduct and adequately report on pharmaceutical-analytical experiments.
- The student critically analyzes the findings to arrive at correct conclusions.
- The student can work together in a team with a focus on results.
The final grade is composed based on the following categories:
Oral Exam determines 50% of the final mark.
PRAC Report determines 30% of the final mark.
Other determines 20% of the final mark.
Within the Oral Exam category, the following assignments need to be completed:
Within the PRAC Report category, the following assignments need to be completed:
Within the Other category, the following assignments need to be completed:
The daily work is assessed individually. The grade (/20) is obtained through daily evaluation by the assistant(s) present and through regular contacts with the person in charge. The evaluation takes into account the efforts made during the practical session, initiative, preparation and participation in the regular discussion with the person in charge.
The grade for daily work and report may be adjusted based on the results of the peer assessment and a discussion with the students involved. This can be both positive and negative, with a maximum of 2 points.
The exam consists of an oral defense of the report (individual). The exam includes both the practical knowledge of the tests performed and the theoretical background.
The final grade is obtained by calculating the weighted average of the results obtained for the report (/30), the daily work (/20) and the oral examination (/50). If a partial result is less than or equal to 8/20, the final grade cannot be higher than the lowest partial result.
A transfer of partial results to second session can be requested with a score of more or equal to 10/20. In case of a fail for the report and/or daily work, an assignment will be given related to the report (e.g. reworking part of or the whole report). The assignment will be communicated individually to the student concerned. Transfer of partial results to a following academic year cannot be requested.
Participation in the examination requires that the students be present for at least 75% of the time of the practical. The 25% tolerated only applies to legitimate absences!!!
Unwarranted absences mean postponement to the next academic year.
This offer is part of the following study plans:
Master of Drug Development: Pharmacist (only offered in Dutch)
Master of Drug Development: AR without officinastage (only offered in Dutch)