Objectives
The essential aim of the course is that graduates 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.
The specific aims of the course are that graduates 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, graduates 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, graduates 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.
The general aims of the course are to stimulate and support scientific thinking, improve written communication skills, and the introduce the basics of the peer-review process.
The essential aim of the course is that graduates 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.
The specific aims of the course are that graduates 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, graduates 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, graduates 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.
The general aims of the course are to stimulate and support scientific thinking, improve written communication skills, and the introduce the basics of the peer-review process.
- Teacher: Päivi Hirvensalo
- Teacher: Markku Koulu
- Teacher: Noora Kulla