During a thematic meeting of the Association of Russian Pharmaceutical Manufacturers (ARPM), leading industry experts in pharmacovigilance and representatives of regulatory authorities discussed current issues on the agenda. The meeting was held on February 26 with the support of Pharmacovigilance Agency “Pharmcompliance” LLC and the Association for Pharmacovigilance.
“Pharmacovigilance is not just about complying with regulatory requirements so that marketing authorizations are not withdrawn,” emphasized Viktor Dmitriev, Chairman of the Public Council under Roszdravnadzor and Head of the ARPM. “It is an integral element of the medicines lifecycle, a living system that saves patients’ lives, identifies and prevents potential risks of pharmacotherapy.”
He noted that in the context of the dynamic development of the domestic pharmaceutical industry and import substitution, patient safety issues must be at the forefront. “Russian manufacturers, like any others, need to deliver high-quality products and demonstrate the reliable operation of their pharmacovigilance systems,” Viktor Dmitriev added.
Vadim Kalinichenko, a representative of the Department for Regulation of Medicines and Medical Devices of the Ministry of Health of the Russian Federation, presented a report on “Pharmacovigilance as the Foundation of a Modern System for Regulating Medicines.” He highlighted the fundamental role of pharmacovigilance in developing the flexibility of the regulatory system and maintaining patient safety when accelerated procedures for bringing innovative medicines to market are used.
One of the most discussed topics among specialists in drug efficacy and safety today concerns the inspection of pharmacovigilance systems of marketing authorization holders. In her presentation “Pharmacovigilance Inspections and Audits,” Anna Kashirskih, CEO of Pharmcompliance and a certified quality management system auditor, identified three elements that underpin successful pharmacovigilance inspections:
- conducting regular internal pharmacovigilance audits;
- ensuring that employees of the organization understand that the inspection is a priority for the entire company, not just the pharmacovigilance department;
- having adequate resources in the company to maintain an effective pharmacovigilance system.
The meeting also highlighted the importance of interaction among all stakeholders in the medicines circulation system for effectively ensuring patient safety. “A well-organized pharmacovigilance system at the state and global level implies close cooperation between regulatory authorities, manufacturers, medical and pharmaceutical professionals, and other participants in the pharmaceutical market in the processes of monitoring the efficacy and safety of medicines,” concluded Ivan Anosov, Chairman of the Association for Pharmacovigilance.