Universitat Internacional de Catalunya
Propiedad Intelectual, Transferencia de Tecnología y Aspectos Regulatorios
Other languages of instruction: Catalan, Spanish,
Teaching staff
Questions will be resolved before or after class.
Introduction
In this subject, the basic concepts of protecting an idea, transferring it to the market and the regulations that must be met to reach the patient will be discussed.
Pre-course requirements
No prerequisites
Objectives
Provide the necessary practical knowledge to be able to execute the different development plans of a company in each of its departments.
Be able to critically reflect on drug development, as well as the different phases of a clinical trial.
Better understand the value chain of the development of drugs, medical devices, and digital health technology for the continuous progression of this process.
Know the most common bottlenecks in the development of these technologies, both at a scientific, commercial, or strategic-practical level.
Introduce students to the latest advances in clinical trials, their regulation, management, and development.
Competences/Learning outcomes of the degree programme
Basic skills:
CB3: That the student can gather and interpret relevant data to make judgments that include reflection on relevant topics of a social, scientific, or ethical nature.
General competencies:
CG2: Integrate the basic concepts related to the biomedical industry both at a theoretical and work level.
Specific competencies:
CE2: Use databases to search for verified information and analyze it critically.
CE3: Interpret the data obtained to solve problems that arise.
CE4: Be able to lead work and colleagues if necessary to meet delivery deadlines.
Learning outcomes of the subject
At the end of the course, the student:
Have acquired advanced knowledge in the different areas of the biomedical industry and the most used methodologies within companies.
Syllabus
Intellectual property, technology transfer and regulatory aspects (4 ECTS)
- Intellectual Property Bases
- Different protection models and how to interpret them
- Search in patent databases
- How to transfer scientific knowledge to the company to reach the market
- What are the different classifications by which a product can be regulated?
- How to pass the health regulation of a product
Teaching and learning activities
In person
• Master classes: Presentation of the contents of the subject orally by a teacher with secondary participation by the students.
• Conferences: Participation in a scientific or technical topic carried out by an expert in a specific subject. It will be related, in some way, to the sequencing of content of a certain subject, to ensure the integration of this type of teaching methodology in the subject in which it is located.
• Information search: Actively carried out by students, it is focused on the acquisition of knowledge autonomously, as well as training for the acquisition of skills and attitudes related to the need to obtain information in a discriminative way.
• Practical classes: Any activity developed through some type of professional technical procedure, always based on the conceptual contents of the master's degree, and following its reasoning.
Evaluation systems and criteria
In person
Class participation and attitude: 20%
Multiple choice exam: 80%
General points to consider about the evaluation system:
You must attend at least 80% of the sessions to pass the subject.
You must obtain a 5 or more in the multiple-choice exam to pass the subject.
Participation in class is understood as the contribution of interesting ideas or the raising of pertinent questions that help improve the quality of the session.
Bibliography and resources
The Entrepreneur's Guide to a Biotech Startup. Peter Kolchinsky. www.evelexa.com. Free download:https://www.ctsi.ucla.edu/researcher resources/files/view/docs/EGBS4_Kolchinsky.pdf
During the course, viewing videos that reinforce or introduce some content will be recommended. Those required viewing will be seen and discussed in class.