Study programme 2020-2021Français
Programme component of Master's in Biomedical Sciences à la Faculty of Medicine and Pharmacy

Students are asked to consult the ECTS course descriptions for each learning activity (AA) to know what special Covid-19 assessment methods are possibly planned for the end of Q3

CodeTypeHead of UE Department’s
contact details
UM-M2-BIOMED-001-MOptional UEDEBAUVE GaëlM101 - FMP - Service du Doyen
  • DEBAUVE Gaël

of instruction
of assessment
HT(*) HTPE(*) HTPS(*) HR(*) HD(*) CreditsWeighting Term
  • Anglais
Anglais15000022.001st term

AA CodeTeaching Activity (AA) HT(*) HTPE(*) HTPS(*) HR(*) HD(*) Term Weighting
Programme component

Objectives of Programme's Learning Outcomes

  • Scientific skills
    • Implement and independently carry out an experimental approach, validate a model by comparing its predications with experimental results, assess the limitations of the model's validity, and identify sources or error.
    • Appropriately select measuring instruments, analyse and process the signal obtained
    • Use basic mathematical tools
    • Be a responsible researcher: - Know how to base their reasoning on data obtained from scientific literature. - Know how to integrate an ethical dimension in their reasoning. - Be loyal (to the facts, to the team, and to intellectual property). - Do not tamper with results. - Do not exploit the work of others. - Demonstrate experimental rigor.
  • Professional integration skills
    • Invest their knowledge and skills in professional scenarios
    • Be in a hierarchical and professional environment, identify their skills and follow procedures, legislation, standards, among other security and safety measures

Learning Outcomes of UE

The objective of this course is to give a clear overview of the main quality standards used in the pharmaceutical industry: current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). We will study the basic principles common to those two quality standards and their specific applications.  

Content of UE

Role of the different industrial departments (Production, Quality Control, Research & Development (R&D), Quality Assurance(QA) + objectives of the regulatory authorities that check the implementation of the quality standards. Basic principles of good manufacturing practices + main differences between GMP and GLP. The focus will be set on the Good Documentation Practices (GDP), the analytical method validation and the equipment qualification.  

Prior Experience

Sans objet  

Type of Assessment for UE in Q1

  • Oral examination
  • Written examination

Q1 UE Assessment Comments

Depending of the number of students, the 1st examination session assessment will consist in: A written part (MCQ: 50%) and a oral part (50%): limited number of students A written part (MCQ + open questions: 100%): high number of students  

Type of Assessment for UE in Q3

  • Oral examination
  • Written examination

Q3 UE Assessment Comments

The 2nd examination session assessment will consist in a written part (MCQ: 50%) and a oral part (50%).  

Type of Resit Assessment for UE in Q1 (BAB1)

  • N/A

Q1 UE Resit Assessment Comments (BAB1)


Type of Teaching Activity/Activities

AAType of Teaching Activity/Activities
  • Cours magistraux
  • Conférences

Mode of delivery

AAMode of delivery
  • Face to face

Required Reading


Required Learning Resources/Tools

AARequired Learning Resources/Tools
M-DOYM-012A pdf copy of the Powerpoint slides presented during the lectures will be available for download onto the Moodle platform    

Recommended Reading


Recommended Learning Resources/Tools

AARecommended Learning Resources/Tools
M-DOYM-012Sans objet    

Other Recommended Reading

AAOther Recommended Reading
M-DOYM-012[1] ICH Q2: Validation of Analytical Procedures: Test and Methodology; CPMP/ICH/381/95 guideline. [2] Guide de Validation des Méthodes en Biologie Médicale;Cofrac, Document LAB GTA04, Révision 00- Juin 2004. [3] Guidance for Industry : Bioanalytical Method Validation;, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001.    

Grade Deferrals of AAs from one year to the next

AAGrade Deferrals of AAs from one year to the next
(*) 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 génération : 09/07/2021
20, place du Parc, B7000 Mons - Belgique
Tél: +32 (0)65 373111