The field of “Regulatory Affairs” covers all the work that is necessary to obtain and sustain a marketing authorisation or registration for a medicinal product. Therefore, the following aspects will be studied:
- Evaluation of existing documents/dossiers;
- Management of marketing authorisation projects:
National marketing authorisation procedures
Mutual recognition procedures (MRP)
Decentralised procedures (DCP)
Centralised procedures (CP)
- Information on clinical studies, medical safety and efficacy trials, medicinal product quality, analytical testing, approved use, pharmacovigilance in an electronic common technical document (eCTD) dossier.