2019-2020 / SBIM2005-1

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

Duration

10h Th, 5h Pr

Number of credits

 Master in biomedicine (120 ECTS)1 crédit 

Lecturer

Christine Grignet, Anne Grogna, 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 Anne Grogna (SUPHT):
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) :
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. 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)

Face to face

Recommended or required readings

Assessment methods and criteria

MCQ (French): the exam will concern a part of the course ((see ($) in the end of the part "Learning unit contents" for the module excluded of the examination)

Work placement(s)

  /

Organizational remarks

The course can be provided in French and/or in English.

Contacts

Christine Grignet: c.grignet@uliege.be
Anne Grogna: Anne.Grogna@uliege.be
Olivier Thellin: o.thellin@uliege.be
Willy Zorzi: willy.zorzi@uliege.be

Adaptation of teaching commitments following the COVID-19 pandemic for the May-June 2020 session

Teaching methods implemented : distance-learning

Assessment subjects

Assessment methods

Contacts

Adaptation of teaching commitments following the COVID-19 pandemic for the Aug-Sept 2020 session

Assessment subjects

Assessment methods

Contacts