 | Study programme 2021-2022 | Français | |
 | GMP-GLP-Validation | ||
Programme component of Master's in Biomedical Sciences à la Faculty of Medicine and Pharmacy |
| Code | Type | Head of UE | Department’s contact details | Teacher(s) |
|---|---|---|---|---|
| UM-M2-BIOMED-001-M | Optional UE | DEBAUVE Gaël | M101 - FMP - Service du Doyen |
|
| Language of instruction | Language of assessment | HT(*) | HTPE(*) | HTPS(*) | HR(*) | HD(*) | Credits | Weighting | Term |
|---|---|---|---|---|---|---|---|---|---|
| Anglais | 15 | 0 | 0 | 0 | 0 | 2 | 2.00 | 1st term |
| AA Code | Teaching Activity (AA) | HT(*) | HTPE(*) | HTPS(*) | HR(*) | HD(*) | Term | Weighting |
|---|---|---|---|---|---|---|---|---|
| M-DOYM-012 | GMP-GLP-Validation | 15 | 0 | 0 | 0 | 0 | Q1 | 100.00% |
| 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 an overview of good documentation and good scientific practices in order to carry out practical lab experiments (e.g. master thesis) in agreement with data integrity principles.
Content of UE
Definition of quality from an analytical point of view, quality in Research (Good Scientific Practices)
Lab work practical consideration (e.g. problem solving methodologies (e.g. 5M), lab organization, (e.g. 5S, stock management), PPE: the right protective equipment for the right task, good pipetting technique)
Elements of Good Documentation Practices: ALCOA, introduction to lab notebook and the working templates
Prior Experience
Not Applicable
Type of Assessment for UE in Q1
- N/A
Q1 UE Assessment Comments
Not Applicable
Type of Assessment for UE in Q3
- N/A
Q3 UE Assessment Comments
Not Applicable
Type of Resit Assessment for UE in Q1 (BAB1)
- N/A
Q1 UE Resit Assessment Comments (BAB1)
Not Applicable
Type of Teaching Activity/Activities
| AA | Type of Teaching Activity/Activities |
|---|---|
| M-DOYM-012 |
|
Mode of delivery
| AA | Mode of delivery |
|---|---|
| M-DOYM-012 |
|
Required Reading
| AA | |
|---|---|
| M-DOYM-012 |
Required Learning Resources/Tools
| AA | Required Learning Resources/Tools |
|---|---|
| M-DOYM-012 | A pdf copy of the Powerpoint slides presented during the lectures will be available for download onto the Moodle platform |
Recommended Reading
| AA | |
|---|---|
| M-DOYM-012 |
Recommended Learning Resources/Tools
| AA | Recommended Learning Resources/Tools |
|---|---|
| M-DOYM-012 | Not applicable |
Other Recommended Reading
| AA | Other 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
| AA | Grade Deferrals of AAs from one year to the next |
|---|---|
| M-DOYM-012 | Authorized |