{"id":null,"code":"DRUG0026","name":{"valueFi":"Drug Regulation","valueEn":"Drug Regulation","valueSv":"Drug Regulation"},"credits":4.0,"minCredits":4,"maxCredits":4,"tags":[],"createdAt":1790534697819,"contentList":[{"title":{"valueFi":"Osaamistavoitteet","valueEn":"Learning outcomes","valueSv":""},"content":{"valueFi":"The essential aim of the course is that students understand and are able to describe the role of regulatory authorities in the drug development and approval processes and that they know the legal framework that regulates the field. \r\nThe specific aims of the course are that students are able to differentiate the general outline of the procedures applied to marketing authorization applications (MAA) in the EU area and in the USA, and are prepared to discuss and assess the actions executed by the main regulatory agencies (EMA and FDA). In addition, students will be able to 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. Furthermore, students will understand and explain the principal methods used in pharmacovigilance, how the safety data of drugs that are already on the market are collected, and how toxicological and safety studies, required by the regulatory bodies for a new drug molecule, are designed and analyzed. \r\nThe general aims of the course are to stimulate and support scientific thinking, improve written communication skills, and introduce the basics of the peer-review process.","valueEn":"The essential aim of the course is that students understand and are able to describe the role of regulatory authorities in the drug development and approval processes and that they know the legal framework that regulates the field. \r\nThe specific aims of the course are that students are able to differentiate the general outline of the procedures applied to marketing authorization applications (MAA) in the EU area and in the USA, and are prepared to discuss and assess the actions executed by the main regulatory agencies (EMA and FDA). In addition, students will be able to 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. Furthermore, students will understand and explain the principal methods used in pharmacovigilance, how the safety data of drugs that are already on the market are collected, and how toxicological and safety studies, required by the regulatory bodies for a new drug molecule, are designed and analyzed. \r\nThe general aims of the course are to stimulate and support scientific thinking, improve written communication skills, and introduce the basics of the peer-review process.","valueSv":"The essential aim of the course is that students understand and are able to describe the role of regulatory authorities in the drug development and approval processes and that they know the legal framework that regulates the field. \r\nThe specific aims of the course are that students are able to differentiate the general outline of the procedures applied to marketing authorization applications (MAA) in the EU area and in the USA, and are prepared to discuss and assess the actions executed by the main regulatory agencies (EMA and FDA). In addition, students will be able to 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. Furthermore, students will understand and explain the principal methods used in pharmacovigilance, how the safety data of drugs that are already on the market are collected, and how toxicological and safety studies, required by the regulatory bodies for a new drug molecule, are designed and analyzed. \r\nThe general aims of the course are to stimulate and support scientific thinking, improve written communication skills, and introduce the basics of the peer-review process."}},{"title":{"valueFi":"Sisältö","valueEn":"Content","valueSv":""},"content":{"valueFi":"This study module consists of topics divided into the following areas: \r\n- 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) and pharmacovigilance activity). \r\n- Regulatory toxicological and safety evaluation studies (acute, sub-acute and chronic toxicity, genotoxicity and mutagenicity, carcinogenicity, reproductive toxicity, environmental toxicity of drugs and their manufacturing procedures and common safety studies). \r\n- Historical drug cases that demonstrate pitfalls in the regulatory processes during past decades. The case studies will utilize the workshop tool in the Moodle platform. \r\n- Workbook essay assignment; a reflection of the course through preconceived questions on the study modules, the lectures, and the drug cases.","valueEn":"This study module consists of topics divided into the following areas: \r\n- 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) and pharmacovigilance activity). \r\n- Regulatory toxicological and safety evaluation studies (acute, sub-acute and chronic toxicity, genotoxicity and mutagenicity, carcinogenicity, reproductive toxicity, environmental toxicity of drugs and their manufacturing procedures and common safety studies). \r\n- Historical drug cases that demonstrate pitfalls in the regulatory processes during past decades. The case studies will utilize the workshop tool in the Moodle platform. \r\n- Workbook essay assignment; a reflection of the course through preconceived questions on the study modules, the lectures, and the drug cases.","valueSv":"This study module consists of topics divided into the following areas: \r\n- 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) and pharmacovigilance activity). \r\n- Regulatory toxicological and safety evaluation studies (acute, sub-acute and chronic toxicity, genotoxicity and mutagenicity, carcinogenicity, reproductive toxicity, environmental toxicity of drugs and their manufacturing procedures and common safety studies). \r\n- Historical drug cases that demonstrate pitfalls in the regulatory processes during past decades. The case studies will utilize the workshop tool in the Moodle platform. \r\n- Workbook essay assignment; a reflection of the course through preconceived questions on the study modules, the lectures, and the drug cases."}},{"title":{"valueFi":"Suoritustavat","valueEn":"Study methods","valueSv":""},"content":{"valueFi":"Lectures (70% mandatory), Final discussion seminar (mandatory), Moodle workshop assignments (i.e., historical cases), individual workbook essay writing.","valueEn":"Lectures (70% mandatory), Final discussion seminar (mandatory), Moodle workshop assignments (i.e., historical cases), individual workbook essay writing.","valueSv":""}},{"title":{"valueFi":"Toteutustavat","valueEn":"Course unit methods","valueSv":""},"content":{"valueFi":"Lectures (approx. 20 h), final seminar (approx. 2 h), independent work with Moodle workshop assignments (approx. 40 h), independent work with workbook assignments (approx. 46 h).","valueEn":"Lectures (approx. 20 h), final seminar (approx. 2 h), independent work with Moodle workshop assignments (approx. 40 h), independent work with workbook assignments (approx. 46 h).","valueSv":""}},{"title":{"valueFi":"Oppimateriaalit","valueEn":"Learning material","valueSv":""},"content":{"valueFi":"Lecture materials including electronic handouts. Databases of the regulatory bodies including FIMEA, EMA and FDA found online. International guidelines (ICH). Relevant review articles and scientific reports.","valueEn":"Lecture materials including electronic handouts. Databases of the regulatory bodies including FIMEA, EMA and FDA found online. International guidelines (ICH). Relevant review articles and scientific reports.","valueSv":""}},{"title":{"valueFi":"Lisätiedot","valueEn":"Further information","valueSv":""},"content":{"valueFi":"Quota for minor studies students is 1-5.","valueEn":"Quota for minor studies students is 1-5.","valueSv":""}},{"title":{"valueFi":"Kurssikirjallisuus","valueEn":"Literature","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Esitietovaatimukset","valueEn":"Qualifications","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointiasteikko","valueEn":"Assessment scale","valueSv":""},"content":{"valueFi":"0-5","valueEn":"0-5","valueSv":"0-5"}},{"title":{"valueFi":"Arviointikriteerit","valueEn":"Assessment criteria","valueSv":""},"content":{"valueFi":"Evaluation criteria are based on the quality of the workbook essays (60%) which include: a) demonstrated knowledge of substance, b) scientific writing skills, c) creativity, and d) adherence to course deadlines. \r\nQuality of performance in workshop assignments (historical cases) and the peer-reviewing process will cover 40% of the final score.","valueEn":"Evaluation criteria are based on the quality of the workbook essays (60%) which include: a) demonstrated knowledge of substance, b) scientific writing skills, c) creativity, and d) adherence to course deadlines. \r\nQuality of performance in workshop assignments (historical cases) and the peer-reviewing process will cover 40% of the final score.","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 2","valueEn":"Assessment criteria 2","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 3","valueEn":"Assessment criteria 3","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Arviointikriteerit 4","valueEn":"Assessment criteria 4","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Kielet","valueEn":"Languages","valueSv":""},"content":{"valueFi":"englanti","valueEn":"English","valueSv":"engelska"}},{"title":{"valueFi":"Taso","valueEn":"Level","valueSv":""},"content":{"valueFi":"Syventävät opinnot","valueEn":"Advanced Studies","valueSv":""}},{"title":{"valueFi":"Oppiaine","valueEn":"Subject","valueSv":""},"content":{"valueFi":"Drug Discovery and Development","valueEn":"Drug Discovery and Development","valueSv":"Drug Discovery and Development"}},{"title":{"valueFi":"Vastuuhenkilöt","valueEn":"Person in charge","valueSv":""},"content":{"valueFi":"Päivi Hirvensalo","valueEn":"Päivi Hirvensalo","valueSv":"Päivi Hirvensalo"}},{"title":{"valueFi":"Luokittelu","valueEn":"Classification","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}},{"title":{"valueFi":"Linkit","valueEn":"Links","valueSv":""},"content":{"valueFi":"","valueEn":"","valueSv":""}}]}