2023-2024 / MCER2020-1

Module III : Drug's life cycle : Regulation and good practices

Duration

76h Th, 8h Pr, 4h Internship

Number of credits

 University certificate in quality assurance as applied to laboratories and chemical, pharmaceutical and biotechnology industries8 crédits 

Lecturer

Lucas Fotsing

Language(s) of instruction

French language

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

During this course dedicated to quality assurance in pharma, students will learn about quality norms, and some useful tools (5M, 3 Why, ...).
Guidelines and norms (Good Manufacturing Practices (GMP), ISO 17025, ...)  will be presented. Finally, validation of analytical methods will be studied in particular, but also risk management, among other.

Learning outcomes of the learning unit

At the end of the course, student will have a knowledge about :
- Quality assurance knowledge (theoritical and practical aspects) - Validation principles for the manufacturing of drugs - Good Manufacturing Practices knowledge (theoritical and practical)

Prerequisite knowledge and skills

None

Planned learning activities and teaching methods

  • Ex cathedra
  • Pratical exercices during course
  • Integrated exercices (groups)

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

Face-to-face

Recommended or required readings

Written evaluation by the end of the course or the period (depending on each course).
Presentation of the integrated exercice
Oral evaluation

Work placement(s)

Organisational remarks and main changes to the course

Course are  given at Q2

Contacts

  • HUBERT Philippe
Département de pharmacie, Bât. B36 Département de pharmacie, CHU, Tour 4, Quartier Hôpital, avenue Hippocrate 15, 4000 Liège 1 Tel. : +32 4 366.43.16 e-mail: ph.hubert@uliege.be
 
  • WIDART Joëlle
Département de pharmacie, Bât. B36 Département de pharmacie, CHU, Tour 4, Quartier Hôpital, avenue Hippocrate 15, 4000 Liège 1 Tel : +32 4 366.44.70 e-mail : jwidart@uliege.be

Association of one or more MOOCs