The aim of the training is to take a brief look at marketing authorisations and to learn how to apply for marketing authorisations and maintain them. The training contains information about different marketing authorisation procedures in EU, application structure, and legal bases. In addition, the training covers maintenance activities such as variations and renewals. Special characteristics of OTC applications and applications for veterinary medicines are also described.
This training is particularly relevant for those working in regulatory affairs and registration in EU (examples and cases are from Finland). It is also of interest to anyone who would find knowledge of the regulatory environment useful (for example QA, clinical safety, pharmacovigilance, and R&D personnel).
Different marketing authorisation procedures
Structure of marketing authorisation applications and legal bases of marketing authorisations
Variations, renewals and special characteristics of over-the-counter (OTC) applications
Special characteristics of applications for veterinary medicines
Completion of the training
It takes about 3–4 hours to complete the training. The training is divided into four modules with different themes. You can work through each module at your own pace. There is also a list of abbreviations available next to the menu.
There is a knowledge test after each module. There is also a final test at the end of the training. You will get a certificate after passing the final test. The certificate will be available on the front page of PharmAcademia online service.
Please register using the registration link on this web page. After registration, you will receive a confirmation email with instructions. The training is available for one month after registration.