5 ECTS credits
150 u studietijd
Aanbieding 1 met studiegidsnummer 4023432DNR voor alle studenten in het 2e semester met een inleidend master niveau.
This course aims to provide Pharmacy students with insight into the newest class of drugs known as "advanced therapy medicinal products" (ATMP). Various aspects of these drugs will be explored, starting with a general introduction where the concept of ATMPs will be defined and compared with other types of drugs, particularly biotechnological drugs. Following this introduction, different classes of ATMPs (such as somatic cell therapy, gene therapy, tissue engineering products, and combined ATMPs) will be discussed individually, covering definitions, historical contexts, current examples, and future perspectives. Exploration of company pipelines and novel formulations of genetic material, with a focus on nanoparticle-formulated RNA-based drugs and vaccines, will also be included.
Furthermore, cancer immunotherapy approaches will be extensively examined and compared with other novel drugs like immune checkpoint inhibitors and tyrosine kinase inhibitors. Subsequently, the course will delve into the juridical, economic, regulatory, and ethical aspects of ATMPs. Finally, the role of ATMPs in clinical (hospital pharmacist) and industrial (industry pharmacist) environments will be discussed. Guest lecturers, experts in their fields, will also contribute by delivering lectures on specific topics.
In the practical courses, students will gain a deeper understanding of topics introduced during the lectures. Emphasis will be placed on independent knowledge acquisition, with the "flipped classroom" approach being employed. Students will prepare themselves thoroughly through self-study of well-described topics before class, where their knowledge will be further explored through group discussions using the Socratic method. These group discussions will involve smaller groups focusing on specific topics, with each group presenting their findings to others who will then contribute to the discussion from their perspectives. The lecturer will guide the discussion by asking direct questions but will not actively steer it. At the end of the practical courses, students will write a report on the addressed topic, where their critical insights and group dynamics will be evaluated.
Additionally, one or more visits to ATMP facilities are planned as part of this course.
To pass the entire course, the student must achieve a minimum score of 9 out of 20 for all course assignment categories (Oral, Practical Course Peer Assessment, and Practical Course Paper). If the student scores 8 or less in any of the three assignment categories, it will result in a fail for the entire course.
Participation in the Practical Course and visits to ATMP facilities is mandatory. Only justified absences will be accepted. A minimum attendance of 75% is necessary to pass the Practical Course.
Use of Generative AI tools such as ChatGPT during the practical course are allowed and even encouraged within the framework of the general guidelines of the VUB on the use of Generative AI. In their group report, students are expected to mention to what extent and for what purposes they have used Generative AI. They should also mention the source they used.
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.
De beoordeling bestaat uit volgende opdrachtcategorieën:
Examen Mondeling bepaalt 70% van het eindcijfer
WPO Groepswerk bepaalt 10% van het eindcijfer
WPO Paper bepaalt 20% van het eindcijfer
Binnen de categorie Examen Mondeling dient men volgende opdrachten af te werken:
Binnen de categorie WPO Groepswerk dient men volgende opdrachten af te werken:
Binnen de categorie WPO Paper dient men volgende opdrachten af te werken:
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.
Deze aanbieding maakt deel uit van de volgende studieplannen:
Master in de geneesmiddelenontwikkeling: apotheker
Master in de geneesmiddelenontwikkeling: Traject zonder officinastage