TYPE: Compulsory
CREDITS: 6 ECTS
COORDINATORS: Gabriela Fuentes

This course will help students to understand the process of developing a healthcare activity: drugs and other biotechnological entities, medical devices, and digital health systems.

In this subject, students will gain a deep understanding of the innovation pathway in health, from laboratory research to market application. The course covers a range of research methodologies, including basic, applied, translational, and clinical approaches, while examining current and future trends. Students will develop a comprehensive grasp of the preclinical setting and the clinical progression of drugs. Furthermore, the curriculum encompasses the clinical advancement of drugs, medical devices, and digital health solutions, as well as an exploration of their regulatory and legal frameworks. Ethical considerations in the development process will be thoroughly discussed. The programme also offers opportunities for visits to notified bodies, encouraging knowledge exchange and hands-on learning experiences.

PROGRAMME

1. From Lab to Market: the innovation pathway in health
2. Basic, applied, translational and clinical research. Current and future trends
3. Preclinic environment description
4. Clinical development of drugs
5. Clinical development of drugs, Medical Devices and Digital Health Solutions
6. Regulatory and legal aspects of drugs, Medical Devices and Digital Health Solutions
7. Ethical Aspects in the development of drugs, Medical Devices and Digital Health Solutions
8. Visit to/from EMA or notified Body
9. Sharing Experiences