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.

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

Knowledge

The student

• can account for and assess different theories and procedures in conventional radiography
• can critically assess the representation of relevant anatomy and pathology in the imaging material
• can account for relevant additional projections for special examinations and consider whether these are relevant
• can critically assess quality and patient safety in the health service
• can critically assess procedures adapted to different groups of patients, for example in geriatrics and paediatrics
• can assess causal connections between post-processing algorithms, radiation doses and image quality

Skills

The student

• can assess image criteria and image quality independently
• can apply post-processing algorithms independently
• can apply methods for quality development work, including patient safety
• can assess different methods of diagnosis in the field of medical diagnostic imaging
• can evaluate their own practice

General competence

The student

• can convey and discuss issues in the field with colleagues, for example radiographers, radiologists, physicists, clinicians and others with whom it is natural to cooperate
• can make ethically and professionally justified assessments and decisions in professional practice
• can formulate, analyse and assess practical and subject-related issues in an independent, systematic and critical manner and on the basis of science
• can identify and assess their own need for competence development and specialisation
• can serve as a resource and driver in development work in the workplace
• can lead optimisation projects and make professional decisions based on systematically obtained research and experience-based knowledge
• can work to safeguard the universal right to equitable health services by focusing on quality and the development of procedures
• can contribute to phasing out and implementing methods, technology and sustainable innovation intended to improve the quality of services

Work and teaching methods include lectures, seminars and skills training. Teaching is largely based on the flipped classroom method. Digital learning resources will be made available to students in advance, and the time they spend at the university will primarily be spent working on assignments and group work.

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

• minimum attendance of 80% at seminars and in skills training
• two individual written assignments of up to 1,000 words
• individual subject note including documentation of 30 selected X-ray examinations and evaluations

Individual written home exam over 3 days with a scope of 3,000 words (+/- 20%).

The paper can be written in English or a Scandinavian language.

All aids are permitted, as long as the rules for source referencing are complied with.

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.

Two years’ experience as a radiographer.

The course is offered as an individual course. Admission requirements:

• Bachelor’s degree or equivalent degree in radiography.