Urgent Safety Restrictions

Course Summary

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.

Purchasing Information

When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.

You will have access to the course module(s) for a period of 180 days after your purchase is complete.

Detailed Course Information

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

Who will benefit from this course

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.

Module Outline

• Module overview
– An outline of the module’s objectives, and notes on terminology.

• Principles
– In this session we define Urgent Safety Restriction and explain its purpose in the European Union and other countries of the European Economic Area. We describe how an USR may be triggered. Finally, we give some examples of safety signals that may, and some that may not, give rise to an USR.

• Procedure
– In this session we describe how to prepare for and initiate an Urgent Safety Restriction (USR) for a centrally authorised product and for a product authorised through the Mutual Recognition or Decentralised Procedure. We outline the 24-hour procedure for execution of an USR, and the follow-up actions required, in each case. Finally, we specify the requirements for a variation application following an USR.

• Assessment
– Multiple-choice mastery assessment.

Drug Safety, Regulatory, Compliance, Manager
CPD Points
Course Study Time
Approx 45 minutes

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