2023-2024 / SBIM2005-1

Regulatory framework for (bio)safety and biorisk management in clinical research

Duration

13h Th, 2h Moni. ex.

Number of credits

 Master in biomedicine (120 ECTS)1 crédit 

Lecturer

Emmanuelle Dinon, Christine Grignet, Olivier Thellin, Willy Zorzi

Language(s) of instruction

English language

Organisation and examination

Teaching in the first semester, review in January

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

Christine Grignet and Emmanuelle Dinon (SUPHT): Partim A

1. Safety:

- BET law, RGPT code

- Danger-risk principles

- Organizational structures

- Roles and responsibilities

2. Biosafety: definition, historical context

3. Legislative aspects concerning pathogens, GMOs and waste management

4. Procedures for GMO and pathogen notification and use

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Willy Zorzi and Olivier Thellin (Human histology service - Faculty of Medicine) : Partim B

1. Biological risk:

- Risk analysis, evaluation and management, communication, precautionary principle

- Classification of pathogens and GMOs

- Biosafety: practical aspects applied to work in laboratories, in the presence of pathogens and GMOs, in cell cultures, in research and development ...

2. Lab acquired infections

3. Elementary rules of biosafety in labs

4. Aerosols: definition, classification and protection measures (HEPA filters)

5. Containment and personal and collective protection measures: classification, equipment, practices, PSE (personal safety equipment), MSC (microbiological safety cabinets), integrative systems,...

6. Transport of "biohazard" material: introduction to biologistics

7. Biosafety aspects related to clinical trials involving medicinal GMO

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8. Emergency plans: introduction and practical situations

9. Problematic cases in biosafety: examples and discussion

10. Instructor-led exercices: practical cases: examples and discussion ($)

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($)= The examination will not concern this module

 

Learning outcomes of the learning unit

Acquisition of theoretical knowledge and practical applications in biosafety allowing future SBIM Masters to manage biosafety and bio-risk management with a maximal level of safety for themselves, the general population and the environment, this according to the regulatory framework and the Good Laboratory Practices

Prerequisite knowledge and skills

- Microbiology
- Molecular biology

Planned learning activities and teaching methods

The "Th" part is provided as ex cathedra courses.
The "Pr" part is provided as directed exercices.

Mode of delivery (face to face, distance learning, hybrid learning)

Face to face

Recommended or required readings

Other : Presence requiring written MCQ exam organized before the regular exam session


Additional information:

MCQ (in French or, following written request by the student, in English): The exam will be organized before the regular exam session and concerns a part of the course content (see ($) in the end of the part "Learning unit contents" for the module excluded of the examination).

The student is declared to have passed the test if he(/she) obtained a score of 10/20 in the total of the "partims A and B" of the course, without having a score lower than 4/10 in each of "partim" A and B" of the course.

Work placement(s)

  /

Organisational remarks and main changes to the course

Partim A: the course and the course notes are provided in French.

Partim B: the course is provided in French, the course notes are in English.

Contacts

Christine Grignet: c.grignet@uliege.be

Emmanuelle Dinon : Emmanuelle.Dinon@uliege.be

Olivier Thellin: o.thellin@uliege.be

Willy Zorzi: willy.zorzi@uliege.be

Association of one or more MOOCs