Study programme 2025-2026Français
Législation, déontologie et éthique pharmaceutique
Programme component of Master's in Pharmacy (MONS) (day schedule)Faculty of Medicine, Pharmacy and Biomedical Sciences

CodeTypeHead of UE Department’s
contact details
Teacher(s)
UM-M2-PHARMA-001-MCompulsory UEKOHL Michel
  • KOHL Michel

Language
of instruction
Language
of assessment
HT(*) HTPE(*) HTPS(*) HR(*) HD(*) CreditsWeighting Term
  • Français
Français36000055.001st term

AA CodeTeaching Activity (AA) HT(*) HTPE(*) HTPS(*) HR(*) HD(*) Term Weighting
M-DOYM-200Législation, déontologie et éthique pharmaceutique360000Q1100.00%

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

AAType of Teaching Activity/Activities
M-DOYM-200
  • Cours magistraux

Mode of delivery

AAMode of delivery
M-DOYM-200
  • Face-to-face

Required Learning Resources/Tools

AARequired Learning Resources/Tools
M-DOYM-200Lecture 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

AARecommended Learning Resources/Tools
M-DOYM-200Power point

Other Recommended Reading

AAOther Recommended Reading
M-DOYM-200see 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

AAGrade Deferrals of AAs from one year to the next
M-DOYM-200Authorized

Term 1 Assessment - type

AAType(s) and mode(s) of Q1 assessment
M-DOYM-200
  • Oral examination - Face-to-face

Term 1 Assessment - comments

AATerm 1 Assessment - comments
M-DOYM-20020 min oral exam / student

 

Resit Assessment - Term 1 (BAB1) - type

AAType(s) and mode(s) of Q1 resit assessment (BAB1)
M-DOYM-200
  • Oral examination - Face-to-face

Resit Assessment - Term 1 (BAB1) - Comments

AAResit Assessment - Term 1 (BAB1) - Comments
M-DOYM-20020 min oral exam / student

 

Term 3 Assessment - type

AAType(s) and mode(s) of Q3 assessment
M-DOYM-200
  • Oral examination - Face-to-face

Term 3 Assessment - comments

AATerm 3 Assessment - comments
M-DOYM-20020 min oral exam / student

 
(*) HT : Hours of theory - HTPE : Hours of in-class exercices - HTPS : hours of practical work - HD : HMiscellaneous time - HR : Hours of remedial classes. - Per. (Period), Y=Year, Q1=1st term et Q2=2nd term
Date de dernière mise à jour de la fiche ECTS par l'enseignant : 22/05/2025
Date de dernière génération automatique de la page : 14/03/2026
20, place du Parc, B7000 Mons - Belgique
Tél: +32 (0)65 373111
Courriel: info.mons@umons.ac.be