FRM3040 – Development of new pharmaceuticals
Course description
Schedule, syllabus and examination date
Course content
This course contains all aspects related to development of new drugs. The students will obtain a chronological understanding of the process "from idea to product" for new drug compounds and other "drug-like products". The main topics in the course are general understanding of the pharmaceutical industry, methodology and process for identification of new drug compounds, patents,requirements for preclinical documentation, implementation of clinical studies and regulatory requirements related to approval of new drugs in Norway and Europe. In addition, the course will deal with topics related to marketing and sale of drugs
Learning outcome
The objective is not to obtain new basic knowledge within the pharmaceutical topics, but to give the students knowledge and understanding for development and documentation of new drugs based on general knowledge from previous courses. The objective is further to provide students with a thorough knowledge of the function and framework conditions for pharmeceutical industry in the society with focus regulatory aspects related to development of new drugs
Admission
The course is only available to students enrolled at the School of Pharmacy at the University of Oslo.
Prerequisites
Formal prerequisite knowledge
In order to participate in this course and to sit for the exam: all earlier Pharmacy courses up to and through FRM3020 must be passed and all manditory activities from FRM3030 must be approved.
Health, Safety and Environment (HSE)
There are compulsory HSE courses at the beginning of the first semester. For students commencing their program from the autumn semester 2015 the following courses are mandatory:
- HMS0501 - Safety and Physical Environment
- HMS0502 - Positive Learning Environment
- HMS0507 - Fire Safety
In addition to this you will have to complete HMS0503 - Laboratory Safety and HMS0506 Patient clinic Safety for participation in Laboratory and clinic-courses in the program.
You will need to provide documentation that you have passed HMS0501, HMS0502 and HMS0507 when you attend the first lecture.
For students who commenced the program from the Autumn semester 2012 up til and including the spring semester 2015 the following courses are mandatory:
- MNHMS0015 - Introduction to Health, Safety and Environment (HSE) (discontinued) or HMS0501 - Safety and Physical Environment and HMS0502 - Positive Learning Environment and HMS0507 - Fire Safety.
- MNHMS0010LS - Introduction to Laboratory Safety (discontinued) or MNHMS0020LS - In-Depth Laboratory Safety (discontinued) or HMS0503 - Laboratory Safety
- MNHMS0015FS - Introduction to Field Safety (discontinued) or HMS0504 Field Safety.
For more information on the HSE courses and transitional arrangements:
http://www.mn.uio.no/english/studies/courses/hse-courses.html
Overlapping courses
10 credits overlap with FRM3510 – Development of new pharmaceuticals (discontinued)
Teaching
Teaching consists of lectures and mini-lectures of 15 minutes length. The mini-lectures are carried out by the students themselves. Themes, distribution and time of mini- lectures will be given on the first day of regular teaching. Mini-lectures are mandatory and 70% participation is required.
Inactivity and / or excessive absences in compulsory education means that the student does not receive final assessment / examination.
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.
Examination
Group project presented by the whole group to the class. All group members will be examined in the whole group project/curriculum. The two days of group presentations have compulsory attendance. Grades are awarded on a pass/fail scale. Before presenting the group project all mandatory teaching (mini-lectures) must be approved.
In addition to the group project a two hour indiviual written exam will be held. All mandatory teaching (mini-lectures) and group project must be approved/passed in order to present oneself for an examination.
Resit or postponed examination: the candidate must present the whole group project and answer questions encompassing the whole group project and course curriculum from the course coordinator and examiner. Since this is an individual evaluering the 2 hours written exam will not be held.
Examination support material
As of 1 August, 2016, the use of own calculators is no longer permitted. Casio FX-991EX calculators are handed out to all exam candidates at the beginning of the exam.
Grading scale
Grades are awarded on a pass/fail scale. Read more about the grading system.
Explanations and appeals
Resit an examination
This course offers both postponed and resit of examination. Read more:
Withdrawal from an examination
It is possible to take the exam up to 3 times. If you withdraw from the exam after the deadline or during the exam, this will be counted as an examination attempt.
Special examination arrangements
Application form, deadline and requirements for special examination arrangements.
Evaluation
The course is subject to continuous evaluation. At regular intervals we also ask students to participate in a more comprehensive evaluation.