In the meeting of the Pharmacovigilance Risk Assessment from 6-9 June 2016, the Committee paying attention on the extensive range of its tasks and responsibilities which cover all characteristics and features of the risk management of the use of medicines.
The PRAC’s full range of work comprises
- Pre-authorization actions
- Consideration of risk-management plans for medicines under assessment
- Post-authorization activities
- Evaluation of periodic safety update reports(PSURs) to re-assess the benefit-risk balance of a medicine throughout its lifecycle on the basis of new data collected.
The PRAC also estimates safety signals, public-health functions that make sure that latest safety issues are swiftly detected, assess and, when suitable, product-labeling changes or limitations are introduced for the benefit of patients.
Date: 10/06/2016