![]() | Study programme 2025-2026 | Français | |
![]() | Législation, déontologie et éthique pharmaceutique | ||
Programme component of Master's in Pharmacy (MONS) (day schedule)Faculty of Medicine, Pharmacy and Biomedical Sciences |
| Code | Type | Head of UE | Department’s contact details | Teacher(s) |
|---|---|---|---|---|
| UM-M2-PHARMA-001-M | Compulsory UE | KOHL Michel |
|
| Language of instruction | Language of assessment | HT(*) | HTPE(*) | HTPS(*) | HR(*) | HD(*) | Credits | Weighting | Term |
|---|---|---|---|---|---|---|---|---|---|
| Français | 36 | 0 | 0 | 0 | 0 | 5 | 5.00 | 1st term |
| AA Code | Teaching Activity (AA) | HT(*) | HTPE(*) | HTPS(*) | HR(*) | HD(*) | Term | Weighting |
|---|---|---|---|---|---|---|---|---|
| M-DOYM-200 | Législation, déontologie et éthique pharmaceutique | 36 | 0 | 0 | 0 | 0 | Q1 | 100.00% |
| Programme component |
|---|
Objectives of Programme's Learning Outcomes
Learning Outcomes of UE
Objectives (and/or specific learning outcomes)
This course aims at the knowledge of the legislation relating to the course of the medicinal product (from its conception to its placing on the market) and of pharmaceutical ethics.
The knowledge and understanding of the rules and standards applied to the pharmaceutical sector makes it possible to approach and better involve the healthcare provider towards responsible and correct ethics.
Contribution to the teaching profile
Perform an appropriate and responsible professional act in accordance with procedures
Deliver medicines and health products by ensuring their correct, rational and SmPC-compliant use, quality and compliance.
Control the conformity and quality of raw materials and finished products upon receipt and storage
Manufacture pharmaceutical preparations (magistral and officinal) and parapharmaceutical in compliance with good pharmacy practices related to order, rigour, precision, quality and cleanliness implemented.
Ensure the traceability of pharmaceutical products in general as well:
During the different stages of production
Appropriately discard expired and/or non-conforming products
Manage a structure dedicated to the handling of health products in order to optimize their operation.
Ensure the global and complete logistics of the various dispensations of the structure (practical, administrative and economic aspects)
Act ethically and responsibly:
Apply and comply with pharmaceutical legislation, ethics and ethics.
Ensuring patient well-being and safety
Apply the regulations in force in the field of health
Behave with morality, probity, dignity, honor, discretion
Maintain a responsible and cordial confraternity among health professionals
UE Content: description and pedagogical relevance
Course Content
The course focuses on legislation relating to medicines, medical devices, food supplements, .... at the pharmacy open to the public, at the hospital pharmacy.
The course covers the concepts of placing the drug on the market, registration, manufacture, import, and distribution of the drug. Scientific information as well as advertising about medicines are also taught.
The main concepts of pharmacovigilance, reimbursement procedures and the measures established to limit the counterfeiting of medicinal products have just been added to this teaching. The course also introduces notions of ethics and includes a presentation of the Order of Pharmacists and the code of pharmaceutical ethics.
Prior Experience
No pre-requisites apart from legal and academic pre-requisites and corequisites
Type of Teaching Activity/Activities
| AA | Type of Teaching Activity/Activities |
|---|---|
| M-DOYM-200 |
|
Mode of delivery
| AA | Mode of delivery |
|---|---|
| M-DOYM-200 |
|
Required Learning Resources/Tools
| AA | Required Learning Resources/Tools |
|---|---|
| M-DOYM-200 | Lecture with written support and an updated and commented power point. Guided case analysis exercises relating to ethical problems at the medical or pharmaceutical level to be carried out in groups (mandatory activity). Not applicable |
Recommended Learning Resources/Tools
| AA | Recommended Learning Resources/Tools |
|---|---|
| M-DOYM-200 | Power point |
Other Recommended Reading
| AA | Other Recommended Reading |
|---|---|
| M-DOYM-200 | see above http://www.fagg-afmps.be/fr/ http://www.ema.europa.eu/ema/ http://www.fda.gov/ http://www.ordredespharmaciens.be/default.aspx?ID=14&PT=2&G=24&GRT=5&lang=2 http://www.health.belgium.be/eportal/Healthcare/Consultativebodies/Commitees/Bioethics/index.htm#.VfGOKxHtlBc http://limo.libis.be/primo_library/libweb/action/search.do?dscnt=0&fromLogin=true&dstmp=1441893964675&vid=VDIC&vid=VDIC&backFromPreferences=true |
Grade Deferrals of AAs from one year to the next
| AA | Grade Deferrals of AAs from one year to the next |
|---|---|
| M-DOYM-200 | Authorized |
Term 1 Assessment - type
| AA | Type(s) and mode(s) of Q1 assessment |
|---|---|
| M-DOYM-200 |
|
Term 1 Assessment - comments
| AA | Term 1 Assessment - comments |
|---|---|
| M-DOYM-200 | 20 min oral exam / student |
Resit Assessment - Term 1 (BAB1) - type
| AA | Type(s) and mode(s) of Q1 resit assessment (BAB1) |
|---|---|
| M-DOYM-200 |
|
Resit Assessment - Term 1 (BAB1) - Comments
| AA | Resit Assessment - Term 1 (BAB1) - Comments |
|---|---|
| M-DOYM-200 | 20 min oral exam / student |
Term 3 Assessment - type
| AA | Type(s) and mode(s) of Q3 assessment |
|---|---|
| M-DOYM-200 |
|
Term 3 Assessment - comments
| AA | Term 3 Assessment - comments |
|---|---|
| M-DOYM-200 | 20 min oral exam / student |