Concept to early-stage Drug and MedTech products
BIO-497 / 4 credits
Teacher(s): Deplancke Bart, Ghisays Haydar Fiorella, Maitra Gautam, Pojer Florence
Language: English
Withdrawal: It is not allowed to withdraw from this subject after the registration deadline.
Summary
This course covers the steps in the development and commercialization of drugs, medical devices, food and nutritional products. The aim is to educate and motivate students to explore career paths in the Life Sciences industry and bridge the acute talent gap in Switzerland.
Content
The course is designed to introduce the basic concepts to early-stage Drug and MedTech products development, as well as to provide regulatory and clinical professionalism to students having little or no exposure to industry.
In addition, it will give the "real world" knowledge and skills to develop solutions to regulatory, clinical, quality and market access challenges. This is done with live case studies, team work and exposure, and presentations by over 13 industry speakers
Topics covered are:
- Concepts and Strategic approach to drug and medical device development
- Regulatory affairs and the role of regulatory professionals
- Quality management system
- Market access challenges
- Project management
- Intellectual property (IP)
- Introduction to food and nutrition products development
Keywords
Industry, Drug and device development, Pre-clinical and clinical trials, Regulatory approval, Market access, Manufactor, FDA/EMA
Learning Prerequisites
Required courses
Bachelor of Sciences
Learning Outcomes
By the end of the course, the student must be able to:
- Master the major steps of the drug and device development process
- Develop skills of early-stage Project Management
- Develop tools to interact with regulators
- Understand the basics of a Quality Management System
- Present a Product Profile for a drug, device or therapy
- Feel more confident about job seeking and job interviews
Transversal skills
- Communicate effectively with professionals from other disciplines.
- Communicate effectively, being understood, including across different languages and cultures.
- Respect relevant legal guidelines and ethical codes for the profession.
Teaching methods
Lectures, external industry speakers, group study
Expected student activities
In person mandatory, group presentation
Assessment methods
During the semester
In the programs
- Semester: Fall
- Number of places: 25
- Exam form: During the semester (winter session)
- Subject examined: Concept to early-stage Drug and MedTech products
- Lecture: 2 Hour(s) per week x 14 weeks
- Exercises: 2 Hour(s) per week x 14 weeks
- Type: optional
- Semester: Fall
- Number of places: 25
- Exam form: During the semester (winter session)
- Subject examined: Concept to early-stage Drug and MedTech products
- Lecture: 2 Hour(s) per week x 14 weeks
- Exercises: 2 Hour(s) per week x 14 weeks
- Type: optional