During this course you will learn about the periodic safety update reports single assessment procedure and informal Work-Sharing procedure for follow-up for PSUSA for nationally authorised products.
The course is divided in to 9 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.
Participating in this course you will learn the objectives of the periodic safety update reports and you will find the information for which medicinal products they must be prepared. You will be shown the way of submission of periodic safety update reports to the PSUR repository of the European Medicinal Agency. You will learn about the periodic safety update reports single assessment procedure. You will study what is the table of lists of nationally authorized medicines involved in PSUR single assessments and regulatory outcomes for and how to use it in practice. Additionally you will learn where to find the PSUSA outcome to implement it to your medicinal product documentation.
In the second part of the course you will learn what were the rationale for developing Informal Work-Sharing procedure for follow-up for PSUSA for nationally authorised products (PSUFU). You will study the prerequisites for successful PSUFU procedure. Furthermore you will learn detailed outlines of the PSUFU procedure. Finally at the end you will learn what are the benefits of the PSUFU procedure.
