Urgent Safety Restrictions
Instructor
Syed Salman
Reviews
Course Overview
An Urgent Safety Restriction (USR) is a regulatory action taken, in response to a safety signal, to make an interim change to the terms of the marketing authorisation for a medicinal product in Europe. This module describes the principles and procedures for USRs.
Learning objectives
- Explain the purpose of Urgent Safety Restrictions in Europe.
- Describe how an USR may be triggered.
- Describe the general regulatory requirements for preparation and initiation of an USR.
- Outline the 24-hour procedure for execution of an USR.
- Specify the requirements for a variation application following an USR.
What You'll Learn?
- All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies with products authorised in Europe should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.