110 http://isa.epfl.ch/imoniteur_ISAP/ itffichecours.txt?path=EPFL.Etu.FicheCours.HeaderFR itffichecours.txt?path=EPFL.Etu.FicheCours.GlobalNav_js fr 2026 945901 6683147 945901 2840683608 2840683608 0 0 Ingenierie des sciences du vivant SV SV Faculté des sciences de la vie School of Life Sciences !itffichecours.htm?ww_i_matiere=3428517689&ww_x_anneeAcad=2840683608&ww_i_section=945901&ww_i_niveau=6683147 1696552884 1696552963 2025-2026 COURSE BOOKLET BIO-497 Concept to early-stage drug and medTech products Concept to early-stage drug and medTech products Lecturers Ghisays Fiorella, Pojer Florence, Tang Li Language of teaching English Cursus Life Sciences Engineering(2025-2026, SV - Master 2024)
Life Sciences Engineering(2025-2026, SV - Master 2025)
SemesterMand.OptionFilières
MA2, MA4x
 Credits 4 Withdrawal Unauthorized It is not allowed to withdraw from this subject after the registration deadline. Session Summer Workload 120h Exam During the semester Number of positions 25 Il n'est pas autorisé de se retirer de cette matière après le délai d'inscription. Semester Spring Weeks 14 Hours 4 weekly
Courses 2 weekly
Exercises 2 weekly
Study planSemesterMand.OptionFilières
Ingénierie des sciences du vivant 2025-26MA2x
Ingénierie des sciences du vivant 2025-26MA4x
Cursus Sem. Type
Life Sciences Engineering MA2, MA4 Opt.
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

 Ingénierie des sciences du vivant, 2025-2026, Master semestre 2 Life Sciences Engineering, 2025-2026, Master semester 2 Ecole polytechnique fédérale de Lausanne EPFL Ecole polytechnique fédérale de Lausanne EPFL 2025-2026 Master semestre 2 MA2 ETE Master semester 2 MA2 Ingénierie des sciences du vivant SV Life Sciences Engineering SV
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
optionnel optional
2 Cours Courses Heure(s) hebdo x 14 semaines Hour(s) per week x 14 weeks H hebdo H hebdo Tang Li 270859
Science et génie des matériaux MX Materials Science and Engineering MX
Ghisays Haydar Fiorella 347377
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
Pojer Florence 180776
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
2 Exercices Exercises Heure(s) hebdo x 14 semaines Hour(s) per week x 14 weeks H hebdo H hebdo Tang Li 270859
Science et génie des matériaux MX Materials Science and Engineering MX
Ghisays Haydar Fiorella 347377
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
Pojer Florence 180776
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
3428517689 Concept to early-stage drug and medTech products Concept to early-stage drug and medTech products 4
Pendant le semestre During the semester Crédit Credits 4 Session été Session summer ETE ETE
Ingénierie des sciences du vivant, 2025-2026, Master semestre 4 Life Sciences Engineering, 2025-2026, Master semester 4 Ecole polytechnique fédérale de Lausanne EPFL Ecole polytechnique fédérale de Lausanne EPFL 2025-2026 Master semestre 4 MA4 ETE Master semester 4 MA4 Ingénierie des sciences du vivant SV Life Sciences Engineering SV
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
optionnel optional
2 Cours Courses Heure(s) hebdo x 14 semaines Hour(s) per week x 14 weeks H hebdo H hebdo Tang Li 270859
Science et génie des matériaux MX Materials Science and Engineering MX
Ghisays Haydar Fiorella 347377
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
Pojer Florence 180776
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
2 Exercices Exercises Heure(s) hebdo x 14 semaines Hour(s) per week x 14 weeks H hebdo H hebdo Tang Li 270859
Science et génie des matériaux MX Materials Science and Engineering MX
Ghisays Haydar Fiorella 347377
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
Pojer Florence 180776
Ingénierie des sciences du vivant SV Life Sciences Engineering SV
3428517689 Concept to early-stage drug and medTech products Concept to early-stage drug and medTech products 4
Pendant le semestre During the semester Crédit Credits 4 Session été Session summer ETE ETE
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