Wed 20 Jul 2016 @ 11:00
Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course: PV06: Urgent Safety Restrictions.
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.
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.