MAFAR4300 Development and Manufacturing of Medicinal Products Course description

This course concerns preclinical aspects of the development and manufacturing of medicinal products, with a particular focus on biological drugs and radiopharmaceuticals, which the pharmaceutical industry must consider before a pharmaceutical product becomes available to the user. Important topics include the choice of lead compounds, mode of action, choice of formulation and documentation of pharmaceutical quality.

The student must have been admitted to the study programme.

After completing the course, the student should have the following overall learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can explain the structural elucidation and structure-activity relationship of various pharmaceutical candidates
• can discuss especially expedient production and formulation strategies for biologics and radiopharmaceuticals
• can explain relevant analytical methods and molecular engineering used in the development and production of biological drugs
• can explain the requirements that apply to documentation of pharmaceutical quality (FDA/EMA) in connection with a marketing authorisation application

Skills

The student

• can critically assess and apply new knowledge about the structure-activity relationship of pharmaceuticals to develop new medicinal products
• can apply relevant legislation on quality assurance of the manufacturing, storage and distribution of medicinal products, with particular emphasis on biological drugs and radiopharmaceuticals
• can identify and elucidate the typical critical stages of the manufacturing and formulation of biological drugs and radiopharmaceuticals
• can apply methods for analysis and quality control of raw materials for biological drugs and radiopharmaceuticals, as well as ready-to-use medicinal products, and assess how deviations affect the quality of the final products

General competence

The student

• can contribute to quality development in the manufacturing of medicinal products
• can contribute to the process of developing a medicinal product until the finished product has been marketed and meet the medical needs of society, at the national and international level, in a sustainable manner

Work and teaching methods include lectures, student-active seminars, as well as project work and other group work. There will also be practical training in the laboratory. Discussions about the course content with fellow students and teachers is emphasised.

For the project work, the students will work in groups to assess relevant original articles related to drug development.

The following must have been approved in order for the student to take the exam:

• A minimum of 90 percent attendance at compulsory teaching activities
• Presentation of a project assignment in groups of 4-5 students

Supervised individual written exam, 5 hours.

Alphanumeric/financial calculator with cleared memory. A digital calculator is available for the student during the exam.

Grade scale A-F.

All answers are assessed by two examiners. An external examiner is used regularly, at a minimum of every third completion of the course. When selecting answers for external evaluation, a minimum of 10 percent of the answers shall be included, with no fewer than 5 answers. The external examiner’s assessment of the selected answers shall benefit all students.

None.