Development of products in the biomedical industry, 12 credits

A Bachelor's degree or a professional degree equivalent to a Swedish Bachelor's degree of at least 180 credits in health care, biomedicine, biology, cellular and molecular biology, pharmaceutics, chemistry, medicine or biotechnology. English language skills equivalent to English B at Swedish upper secondary school.

This course aims to introduce the students to the product development process in the life science sector, that is biotechnology, pharmaceuticals and medtech.

Upon completion of the course, the student should be able to:

• explain the basics of product development in the life science sector,
• relate product innovations to economic, technological and institutional aspects,
• analyse how the product development process differs between large and small molecular pharmaceuticals and medical devices,
• evaluate product related risks and clearly describe and argue the role of regulatory bodies in influencing product development,
• account for the quality control systems and standards used in product development,
• assess and compare different types of intellectual property (IP) and patent strategies as well as perform basic IP analyses,
• account for different reimbursment systems' importance for pricing and the importance of acknowledging these aspects at early phases of product planning,
• carry out advanced tasks within specified time limits.

This course deals with the process of product development in the life science sector.
Emphasis is put on the legal and regulatory frameworks of product development. This includes patents and other forms of protection of intellectual property rights (IPR) and the national and international regulatory frameworks assuring product quality and patient safety.

The course will cover the following themes:

• Introduction to product development
• Intellectual Property Rights
• The product development process in large molecular and small molecular pharmaceuticals
• The product development process in selected fields of medtech
• Cost-effectiveness requirements, evidence and reimbursement in relation to product development
• Regulatory requirements in relation to the product development process.

The course consists of lectures, seminars and workshops as well as case and project work. Literature seminars will also be included. 
 

The examination consists of a case essay (Fail/Pass), a project report in the form of a group work (Fail/Pass/Pass with distinction), an individiual reflection (Fail/Pass/Pass with distinction), opposition on another groups project (Fail/Pass), and a written examination (Fail/Pass/Pass with distinction).

To get the grade pass on the entire course, the student needs to get the grade pass on all examinations. To get a pass with distinction on the entire course, the student needs to get the grade pass with distinction on the written exam and pass with distinction on one out of the two following examinations: the project report or the individual reflection, and the grade pass on the other examinations.

Compulsary participation
Participation at seminars, work shops and presentations is compulsory. The course director assesses if and, in that case, how absence can be compensated. Before the student has participated in all compulsory parts or compensated absence in accordance with the course director's instructions, the student's results for respective part will not be registered in LADOK.
 

After each course occasion there will be at least six occasions for the examination within a two-year period from the end of the course.

The course language is English.

Course evaluation will be carried out in accordance with the guidelines established by the Board of Higher Education.

Oral evaluation in the form of course council meetings will be carried out during the course.