Pisa, Italy

The Law, Economics and Engineering of Advanced Medical Technologies

online course
when 17 January 2022 - 28 January 2022
language English
duration 2 weeks
credits 6 EC
fee EUR 250

'The Law, Economics and Engineering of Advanced Medical Technologies' is an international Winter School addressed to graduate students, young researchers and professionals, part of the three-year Jean Monnet Module “European Health Law and Technology/ELaTe”, awarded in the framework of the Call for proposals 2019 – EAC-A02-2019 under the Erasmus+ Programme.
The school expands on the Project-Based Learning (PBL) methodology successfully applied in the Winter School "European Health Law & Biotechnology” (February 2021).

Teaching activities will be carried out three days per week and be divided in morning lectures on the fundamentals of European health law, medical devices design, HTA and market analysis. During the afternoon sessions participants will work in small cross-disciplinary teams (max 4/5 people), centered on the development of a particular medical device. The final examination will consist of the presentation of a project.

The School will unfold online, three days per week, from the 4th to the 22d of October 2021 for a total of 63 hours. Classes begin at 10.00 AM and end at 6.30 PM, with an hour and a half break for lunch. Each class is 1.30 hours long, with a 30-minutes’ break.
Six academic credits (in accordance with the European Credits Transfer and Accumulation System - ECTS) will be awarded upon successful completion of the Course, which requires the attendance of at least 90% of classes and passing the final examination.
The teaching body includes academics from different backgrounds, such as law, engineering, management and innovation, offering a highly interdisciplinary perspective.
All classes will be taught in English.

Course leader

Dr. Carmelo De Maria

Target group

This Course is designed for national and international students from different backgrounds at an advanced stage of their university-career (graduate students), young researchers (PhDs candidates) in the field of law, social sciences, engineering, economics and management; professionals working for public or private organizations in the healthcare sector.

Course aim

"The Law, Economics and Engineering of Advanced Medical Technologies" is meant to offer participants a state-of-the-art understanding of the European framework for medical technologies.

In the realm of both social sciences and engineering, it is essential to convey the importance of a cross-disciplinary approach and introduce the students to the most relevant issues and competences in this field. This course—designed as an experiment in cross-fertilization among students and teachers from different backgrounds—is aimed at providing these competences and skills.

Participants with a background in Law, Economics, and Bioengineering will earn the knowledge and skills required to identify and discuss the issues raised by the development of advanced medical devices, incl. compliance with applicable regulations, risk-management strategies, the individual rights and social interests (either positively or negatively) affected by technological innovation in healthcare.

Classes will address the following topics:

Week One: Safety-by-Design

- Certification
- Technical Standards
- Risk-based design

Week Two: Fundamental Rights and Social Interests

- Compliance and Liability
- Consent and Ownership
- Intellectual Property Rights and Open Source Medical Devices
- Ethical assessment of Technological Innovation

Week Three: The Market for Medical Devices

- Business Models
- Strategic and Operational Marketing
- Health Technology Assessment

Fee info

EUR 250: tuition fees

Register for this course
on course website