5 ECTS credits
150 h study time
Offer 1 with catalog number 4023432DNR for all students in the 2nd semester at a (D) Master - preliminary level.
This course envisages to offer insight to the Pharmacy student into the newest class of drugs, the “advanced therapy medicinal products” (ATMP). Various aspects of these drugs will be discussed in this course. The course begins with a general introduction in which the concept ATMP will be introduced and this class of drugs will be defined and subsequently compared and contrasted with other types of drugs especially with respect to biotechnological drugs. After this introduction, different classes of ATMP (somatic cell therapy, gene therapy, tissue engineering products and combined ATMP) will be discussed separately: definitions, historical framework, current examples and future perspectives will be discussed for each type. Company pipelines will be explored. Novel formulations of genetic material will be described, with a special focus on nanoparticle-formulated RNA-based drugs and vaccines. Cancer immunotherapy approaches will be extensively discussed and compared with other novel drugs such as immune checkpoint inhibitors blockers and tyrosine kinase inhibitors. Subsequently, juridical, economic, regulatory and ethical aspects of ATMPs will be explained. Finally, the role of ATMP in a clinical (hospital pharmacist) and industrial environment (industry pharmacist) will be discussed. In addition to the courses by the responsible lecturer, a number of guest lecturers who are experts in their domain, will give guest lectures about specific topics.
In the practical courses, a deeper insight will be provided about topics introduced during the lectures. Independent acquisition of knowledge is central here. The principle of “flipping the classroom” is applied, whereby students thoroughly prepare themselves for class through self-study of well-described topics, where this knowledge is further deepened. This will happen through group discussions according to the Socratic method, where students are divided in smaller groups per topic. Within these groups, the topics are first discussed after which they are presented to the other groups, who then participate in the discussion according to their point of view. The lecturer does not have a steering role and does not actively engage in the discussion but rather leads it in the right direction by asking direct questions. At the end of the practical courses, each student writes a paper about the topic that was addressed where the critical insight of the student will be evaluated.
One or more visits to ATMP facilities are planned within this course.
The student is expected to obtain at least 9/20 for all the course assignment categories (Oral, Practical course peer assessment and Practical course paper) in order to pass for the entire course. If the student obtains 8 or less on one of the three assignment categories, this will be the final of the exam. Participation in the Practical course and visits of ATMP facilities is obligatory. Only justified absence will be tolerated.
Cognitive skills:
The student can give examples for each class of ATMP and can describe them
The student can explain various aspects of ATMP (scientific, economic, ethical, regulatory, legal) and compare/contrast this to other types of drugs.
The student can make links between ATMP and other types of drugs (especially biotechnological drugs) used for the same indication.
Reactive skills:
The student actively participates in the discussion during the Practical course
The student constructively collaborates with other members of her/his group.
The student displays a capacity for critical reflection and respects the opinion of others.
The final grade is composed based on the following categories:
Oral Exam determines 70% of the final mark.
PRAC Teamwork determines 10% of the final mark.
PRAC Paper determines 20% of the final mark.
Within the Oral Exam category, the following assignments need to be completed:
Within the PRAC Teamwork category, the following assignments need to be completed:
Within the PRAC Paper category, the following assignments need to be completed:
Lectures (HOC): oral exam with written preparation. The exam not only gauges the knowledge of the course content but also overall insight and the critical mindset of the student.
Practical courses (WPO): In the first instance, presence and active participation during Practical courses will be evaluated based on form, content, source reference, originality and critical reflection.
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)