Concept to early-stage drug and medTech products

BIO-497 / 4 crédits

Enseignant(s): Ghisays Haydar Fiorella, Pojer Florence, Tang Li

Langue: Anglais

Withdrawal: It is not allowed to withdraw from this subject after the registration deadline.

Summary

This course explores how innovative drugs and medical devices are brought to the market. Experts from leading companies share real-world insights and experiences. By the end, students gain a clear and practical understanding of the clinical, regulatory and quality aspects.

Content

The course introduces key concepts in early-stage drug and Medtech development, aimed at students with little or no industry experience. It provides practical knowledge and skills to address biotech and medtech challenges through case studies, teamwork and interactive lectures by industry experts.

 

Topics include:

  • Drug and device development strategies
  • Clinical trials
  • Project management
  • Regulatory aspects
  • Quality management
  • Market access
  • Intellectual property

Keywords

Drug and device development, Pre-clinical and clinical trials,  FDA/EMA

Learning Outcomes

By the end of the course, the student must be able to:

  • Explain the major steps of the drug and device development process
  • Discuss pre-clinical and clinical trials
  • Define Intellectual property

Transversal skills

  • Respect relevant legal guidelines and ethical codes for the profession.
  • Communicate effectively, being understood, including across different languages and cultures.

Teaching methods

Lectures from external industry speakers

Hands-on session in small groups on case studies

Expected student activities

In-person attendance is expected for all  sessions


Assessment methods

Presentations (case studies) in small groups

Dans les plans d'études

  • Semestre: Printemps
  • Nombre de places: 25
  • Forme de l'examen: Pendant le semestre (session d'été)
  • Matière examinée: Concept to early-stage drug and medTech products
  • Cours: 2 Heure(s) hebdo x 14 semaines
  • Exercices: 2 Heure(s) hebdo x 14 semaines
  • Type: optionnel
  • Semestre: Printemps
  • Nombre de places: 25
  • Forme de l'examen: Pendant le semestre (session d'été)
  • Matière examinée: Concept to early-stage drug and medTech products
  • Cours: 2 Heure(s) hebdo x 14 semaines
  • Exercices: 2 Heure(s) hebdo x 14 semaines
  • Type: optionnel

Semaine de référence

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