Curricula Guides

Uusi opinto-opas (sisältäen myös opetusohjelmat) lukuvuodelle 2018-2019 sijaitsee osoitteessa https://opas.peppi.utu.fi . Tältä sivustolta löytyvät enää vanhat opinto-oppaat ja opetusohjelmat.

The new study guide (incl. teaching schedules) for academic year 2018-2019 can be found at https://studyguide.utu.fi. This site contains only previous years' guides.

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Archived Curricula Guide 2016–2018
Curricula Guide is archieved. Please refer to current Curricula Guides
DRUG0006 Drug regulatory science 4 ECTS
Organised by
Drug Discovery and Development
Person in charge
Markku Koulu

Learning outcomes

The aim of the study module is that students can understand and explain the role of regulatory authorities in the drug development and approval process and that they know the legal framework that regulates the field. Students are able to describe the general outline of the procedures applied to marketing authorization applications (MAA) in the European Union and in the USA, and discuss the actions executed by the main regulatory agencies (EMA and FDA). Students are familiar with concepts such as "summary of product characteristics", "orphan drug status", "accelerated application" and "scientific advice". Furthermore, students can describe how the different sections of MAAs are organized according to the common technical document (CTD) format and how data are presented to demonstrate the pharmaceutical quality, efficacy and safety of a new drug. Students can describe methods used in pharmacovigilance in order to collect safety data of drugs that are already on the market. Furthermore, students can design and analyze regulatory toxicological and safety studies required of a new drug molecule. In addition, students will be able to critically analyze interesting regulatory science cases. As built-in component, students practice communication skills by preparing scientific presentations in form of seminars and by writing report on lab work.

Contents

This study module consists of topics divided into the following areas: a) role and activities of drug regulatory authorities in the European Union and in the USA (legal frameworks, guidelines, procedures used in the marketing authorization application, European Medicines Agency (EMA), Food and Drug Administration (FDA), Finnish Medicines Agency (FIMEA), common technical document format (CTD), pharmacolovigilance activity), b) regulatory toxicological and safety evaluation studies (acute, subacute and chronic toxicity, genotoxicity and mutagenicity, carcinogenicity, reproductive toxicity, environmental toxicity of drugs and their manufacturing procedures, common safety studies), c) historical cases in drug regulatory science (e.g. thalidomide, clozapine, COX2-inhibitors, terfenadine, Pandemrix).

Teaching methods

Lectures (30 h), seminars (20 h), work book assignments (40 h) and preparation of seminar presentations (10 h).

Teaching language

English

Modes of study

Lectures (30 h), seminars (20 h), work book assignments (40 h) and preparation of seminar presentations (10 h).

Evaluation and evaluation criteria

Numeric 0-5.
Evaluation criteria are based on the work book outcome (80 %). Evaluation criteria are: a) demonstrated knowledge of substance, b) scientific writing skills, c) creativity and d) keeping up with the given time frame. Quality of the seminar presentations cover 20 % of the final score.

Recommended year of study

1. year autumn

Study materials

Databases available on web pages of FIMEA, EMA and FDA. ICH guidelines. Relevant review articles and scientific reports.

Belongs to following study modules

Institute of Biomedicine
Department of Chemistry
2018–2019
Teaching
Archived Teaching Schedule. Please refer to current Teaching Shedule.
Implementation details are unavailable.
Institute of Biomedicine
DP in Biomedicine
Finnish Study Modules
MDP in Drug Discovery and Development
MDP in Biomedical Imaging
Biomedical Imaging