DELETED: The marketing authorization for medicineLaajuus (3 cr)

Objective

Students are able to explain European drug regulatory authorities and search information from the relevant guidelines. Students are able to explain marketing authorization procedures and the application dossier for marketing authorization.

Content

Students will get to know European drug regulatory authorities and laws and guidelines. Students will get to know the different marketing authorization procedures: Centralized; decentralized, mutual recognition and national procedures. Students will also get to know the application dossier for marketing authorization. PR/FA students will have 3 ects of course, health economics can only make 2 ects part of course.

Qualifications

Previous studies: Lääkkeiden hyvät tuotanto- ja jakelutavat, Lääkkeet terveydenhuollossa Recommended previous studies: Teollisuusfarmasian perusteet

Further information

Teachers:Maija Lahtela-Kakkonen, Tarja Toropainen Time: Spring semester Offering data: 1) First priority PR4/PR5 2) Second priority students of FA3 who fulfil the prerequisite (see prerequisities). In case of standoff the study success in the courses (see prerequisities) will be criteria. 3) Third priority students of toxicology who fulfil the prerequisite (see prerequisities) and students of health economics who fulfil the prerequisite (see prerequisities). Maximum 50 students are annually accepted to the course. Campus: Kuopio Further information: maija.lahtela-kakkonen(at)uef.fi office: hilkka.wessman(at)uef.fi

Execution methods

Lectures 12 h in Moodle, Moodle exercises, electronic exam The marketing authorization for medicine is web course that has predefined schedule. This means that each subject including web exercise and exam will be available only in certain time, usually 1 week, and they needs to be accepted at that time. Next subject opens after the previous one is finished. Each subject has reserved about 1 week, except for marketing authorization application there is reserved 3 weeks.

Accomplishment methods

Modes of study: Course info, online lectures 12 h, marketing authorization info, learning assignments, independent study 67 h. Evaluation criteria: To pass the course you have to do the exercise according to the instructions and evaluation criteria and pass the electronic exam.