FARM4120 – Drug Development
Course description
Course content
The course will provide students with a balanced insight into all aspects of sustainable drug development and provide an understanding of the process "from idea to product". The course will provide students with competence regarding the regulatory aspects related to the approval of new drugs in Norway and Europe as well as the requirements that are necessary to document quality, safety and effect of the new drug. The clinical documentation will be especially emphasized and the course will provide the students with a good competence regarding the various aspects of planning and conducting clinical drug trials (Good Clinical Practice, GCP). Students will also become familiar with terms that are relevant in pharmaceutical practice, such as Clinical Research Associate (CRA) and Qualified Person (QP).
Learning outcome
After completing the course
- you understand the process necessary for discovery, identification and development of new drug substances
- you have broad knowledge regarding optimization of possible new molecular entities and the requirements for the preclinical development
- you have broad knowledge of the documentation required to demonstrate chemical/pharmaceutical/biological quality of the drug
- you have broad knowledge of the different phases of clinical drug trials and a thorough understanding of the benefit-risk concept
- you have knowledge regarding the regulatory aspects and are familiar with relevant legislation and regulations related to the approval of drug/products in Norway and Europe
- you can, in collaboration with others, prepare a protocol for a clinical drug trial, and present the requirements that are necessary to document quality, safety and effect of the drug for colleagues
Admission to the course
The course is only available to students enrolled at the Department of Pharmacy at the University of Oslo.
Formal prerequisite knowledge
- FARM1100 – Pharmaceutical Chemistry
- FARM1110 – Pharmacology, Physiology and Cell Biology 1
- FARM1120 – Social Pharmacy
- FARM1130 – Pharmaceutically Based Organic Chemistry
- FARM1140 – Pharmacology, Physiology and Cell Biology 2
- FARM1150 – Pharmaceutical Based Biochemistry
- FARM2100 – Medicinal Chemistry
- FARM2110 – Pharmacotherapy 1
- FARM2120 – Pharmaceutics and Biopharmaceutics
- FARM2130 – Pharmaceutical Analytical Chemistry
- FARM2140 – Pharmaceutical Microbiology
- FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production
- FARM3100 – Pharmacognosy
- FARM3110 – Pharmacotherapy 2
- FARM3120 – Medicine Use and Public Health
- completed and approved pharmacy practice period in FARM3130 – Advanced Pharmacy Practice Experience (APPE)
- passed the compulsory HSE-courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety and HMS0507 – Fire Safety required for students at the 5-year Master`s Programme in Pharmacy.
For students admitted to the 5-year Master`s Programme in Pharmacy until and including 2016 and who have been transferred from the old study plan, separate formal prerequisite knowledge apply. These are in professional compliance with the formal prerequisite knowledge that apply to the course, but may be replaced by courses from the old study plan, as well as transitional courses. Students on transitional arrangements may contact the study administration for a complete overview of the formal prerequisite knowledge required.
Course exemption:
Laws and regulations describing the overall learning outcome regulate the Pharmacy programme.?Exemptions are only granted if all learning outcomes in the course are covered.
Overlapping courses
- 5 credits overlap with FRM3040 – Development of new pharmaceuticals (discontinued).
- 5 credits overlap with FRM5730 – Clinical Drug Trials (discontinued).
Teaching
Lectures and student active teaching, including a project assignment and presentation, colloquiums and seminars.
- 32 hours of lectures
- 48 hours of student active teaching, including colloquiums, seminars and project assignment?
Compulsory participation in the course must be completed and compulsory submissions must be approved to pass the exam.?Read more about what applies in the event of absence from compulsory activities.
Access to teaching
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
Compulsory participation and approved assignments are valid for 3 years.
Examination
- Final written exam, 3 hours, which counts 60?% towards the final?grade.?
- Project assignment, counting 40 % towards?the final grade.
?Both written exam and project assignment must be passed to pass the course.
For admission to the exam the following must be passed:
- Project assignment and presentation of this.
Examination support material
No examination support material is allowed.
Language of examination
The examination text is given in Norwegian. You may submit your response in Norwegian, Swedish or Danish.
Grading scale
Grades are awarded on a scale from A to F, where A is the best grade and F?is a fail. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more:
More about examinations at UiO
- Use of sources and citations
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.