Drug Life Cycle Project (B-KUL-K09L4A)
Aims
Learning goals:
The aim of this course is to integrate knowledge gained during an academic Bachelor, as well as during the course ‘Drug life cycle’, in a project. This project will be a practical challenge a sponsor (academic lab, pharmaceutical company, etc.) is confronted with.
The student:
- Can identify, interpret, and analyze existing challenges and is able to handle these in a creative and critical way, based on existing knowledge of different phases and regulations of the drug development process.
- Can identify, justify, evaluate and adjust, if necessary, goals and methods of a project in a team.
- Can plan activities in a realistic way, define clear milestones and intermediate targets and is able to meet the deadlines.
- Can communicate both written and orally and report concise the progress of the project, as well as final results.
- Can draw conclusions and propose decisions based on research data of individual disciplines in the field of drug development (depending on the chosen specialization track).
Educational goals:
The student:
- Develops as a self-reliant, independent person.
- Learns to function in a team in a constructive, productive and pro-active way.
- Develops as a team player in a diverse and interdisciplinary team.
- Recognizes the need for interdisciplinary cooperation in every aspect of the drug development process.
- Develops the ability to make decisions in complex situations occurring during the drug development process.
- Develops basic management techniques needed in a team (chairing a meeting, making notes, time management, etc.).
- Develops optimal presentation skills, both (non)verbal as well as via audiovisual media, with attention for written text.
Previous knowledge
- The student has a Bachelor’s degree in Pharmaceutical Sciences
- The student is able to examine complex problems and situations critically
- The student is willing to cooperate in a team
- The student shows initiative and is willing to work independently
To take this course, you must have obtained your Bachelor’s degree in Pharmaceuticals Sciences. Students may only take this course if they are not more than 9 ECTS away of their Bachelor’s degree at the start of the academic year, and meet the additional prerequisites.
Order of Enrolment
Mixed prerequisite:
You may only take this course if you comply with the prerequisites. Prerequisites can be strict or flexible, or can imply simultaneity. A degree level can be also be a prerequisite.
Explanation:
STRICT: You may only take this course if you have passed or applied tolerance for the courses for which this condition is set.
FLEXIBLE: You may only take this course if you have previously taken the courses for which this condition is set.
SIMULTANEOUS: You may only take this course if you also take the courses for which this condition is set (or have taken them previously).
DEGREE: You may only take this course if you have obtained this degree level.
SIMULTANEOUS(K09L2A)
The codes of the course units mentioned above correspond to the following course descriptions:
K09L2A : Levenscyclus van het geneesmiddel
This course unit is a prerequisite for taking the following course units:
K09M8A : Drug Discovery: From Target To Design
K09N1A : Advanced Biotherapeutics, Pharmacogenomics and Precision Medicine
K09N2A : Advanced Drug Development
K09N5A : Regulatory Affairs and Market Access
K09N6A : Pharmaceutical Economics and Management
Is included in these courses of study
Activities
8 ects. Drug Life Cycle Project (B-KUL-K09L4a)
Content
- Introduction to the project. Possible topics (related to a specific problem, hypothesis and/or research question) will vary from year to year.
- Situate state-of-the-art based on international literature and/or analysis of an organization (i.e. pharmaceutical company), discussion of literature
- Development of a project plan (problem, definition of milestones and deliverables, experimental planning).
- Data collection (via literature review and/or interviews at an organization) and/or the conceptual design.
- Analysis of collected information
- Synthesis and oral and written communication on the studied topic.
- Final report and end product.
Course material
Students can use study materials from previous (or concomitant) courses (e.g., ‘Drug life cycle’) to solve the research question of the project. In addition, students independently search for study materials that help them carry out the project bot quantitatively and qualitatively.
Depending on the chosen subject, students also learn to work with specific tools (e.g., statistical software) or equipment needed to execute the project.
Language of instruction: more information
English is the main language in all aspects of the domain of drug development.
Format: more information
Students work in a team with a common objective and research question. Except for the introductory session and obligatory supporting sessions, the students organize the teamwork themselves in order to meet agreed milestones (e.g., interim reports, final report, presentation, …). During the project, the students are monitored by (a) supervisor(s) and professor, and they have to report regularly on their progress (‘milestones’). In supporting sessions the students will gain more insight in topics related to teamwork, for example project management, communication, etc.
At the final presentation, fellow students, supervisors, professors and also external experts will be present.
Evaluation
Evaluation: Drug Life Cycle Project (B-KUL-K29L4a)
Explanation
The global evaluation is made based on the opinion of the supervising team (assessments A-D (see further)), the coordinator (assessments B-C), and an external expert* (assessments A-C) and by the peer team-students (assessment E). A student has to pass all assessments (A-E) to pass the course. The following assessments and relative scores (RS) apply:
2.1. Team-based assessments (RS 50/100):
(A) Project report
(B) PP Presentation
2.2 Individual assessments (RS 50/100):
(C) PP Presentation
(D) In-Process evaluation
(E) Peer-assessment
Specific criteria for each assessment will be announced at the beginning of each academic year when students receive the protocol for that year.
* an external expert (KU Leuven, or pharmaceutical industry) is selected, contacted and invited by the student team
Information about retaking exams
A second examination chance is possible in the following situations:
- A student has not (or only partly) executed the project due to special individual circumstances
- The end product or final report was found to be substandard by the jury
In both situations a remediation trajectory or task is drafted in consultation with the supervisors. The student contacts the supervisors not later than 1 week after publication of the results of the examinations.