On July 27, the Federal Service for Surveillance in Healthcare chaired by the Head of Roszdravnadzor Mikhail Murashko held public hearings on the compliance practice review results in the second quarter of 2017.
The event covered the following issues:
- routine and large-scale violations of mandatory requirements revealed in the course of supervisory activities as part of the state control of the quality and safety of medical activity;
- the review of compliance practices in medical devices regulatory area, typical violations detected in the course of supervisory activities;
- principal offences committed by legal entities and individual entrepreneurs when handling medicines;
- compliance practice results on medicines quality issues, the disposal of medicines, the control over preclinical and clinical trials of medical products;
- the new pharmacovigilance requirements;
- the formation and introduction of the risk-based approach in the implementation of the state control over the quality and safety of medical activities.
At the end of the public hearings, the representatives of the professional community received answers to the posed questions from Roszdravnadzor experts, and the Head of the Service Mikhail Murashko answered questions from the media.