General provisions

The course is part of the Master's Programme in Biopharmaceuticals.

Entry requirements

Admitted to the Master's Programme in Biopharmaceuticals and participated in prior courses on the program.

Learning outcomes

On completion of the course the student should be able to:

* Account for the life cycle of biological drugs from first human studies to introduction of biosimilars and phasing out of the original product

* Apply basic ethical reasoning on clinical trials and registry studies of biological medicines

* Describe and compare different international processes, requirements, and regulatory decisions and health technological assessments (HTA) of biological drugs and biosimilars

* Describe principles and methods for assessing the effect and safety of biological medicines

* Interpret and explain health economic calculations for biological drugs.

* Analyze utilization of biological drugs from global health, socio-economic and ecological sustainability perspectives

* Use different types of registries and models to conduct observational studies of the utilization of biological drugs in society

Content

The focus of the course is on understanding biological drugs, how they are used from the first studies on humans through approval and market entry to phase out and the gradual introduction of biosimilars i.e., "copies" to patent-expired biological drugs. The course prepares the students to be able to make ethical decisions and describe how to assess the effectiveness and safety of pharmaceuticals. The student acquires knowledge of how regulatory systems and health technology assessment (HTA) works and gain an understanding of legislation regarding biological drugs.

The students gain knowledge about global health, economic and ecological sustainability of biological drugs. Students will also visit a healthcare clinic aiming to provide different perspectives on challenges and opportunities surrounding biological drugs when used by patients in healthcare. In addition, students learn to conduct health economic calculations such as cost-effectiveness analysis and to develop their analytical skills throughout the course.

Instruction

The forms of teaching will be lectures, seminars, and a study visit. The course is given in English including both traditional teaching at campus and digital sessions involving guest lecturers. Exercises in oral and written presentation. Written paper and related presentations are mandatory.

Assessment

Written paper including written and oral presentation (3.5 credits) and written exam (4 credits) arranged at the end of the course. 

If there are special needs, the examiner may make exceptions to the specified examination method and allow an individual student to be examined in another way. Special reasons may include, for example, the announcement of special pedagogical support from the University Coordinator for Students with Disabilities.