Dear colleagues!
We invite you on December 15, 2021 to the annual scientific and practical online conference on pharmacovigilance, organized by the Pirogov Russian National Research Medical University, an autonomous non-profit organization «National Scientific Center for Pharmacovigilance», with the support of the company «Aforum». Within the framework of the conference, it is planned to discuss the main practical aspects of the development of a system for ensuring the safety and effectiveness of drugs being developed and manufactured.
Experts from the Ministry of Health of the Russian Federation, the Federal Service for Healthcare Supervision, the Department of Technical Regulation and Accreditation under the EAEU, the Federal State Budgetary Institution «NCESMP» of the Ministry of Health of Russia, the Ministries of Health of the Republics of Kazakhstan, Belarus, Armenia, Uzbekistan, Azerbaijan, the Kyrgyz Republic, scientific and educational organizations and representatives of the pharmaceutical industry are invited to participate in the conference.
The conference will address topical issues:
- Regulatory aspects of pharmacovigilance system inspections;
- Requirements for pharmacovigilance documents as part of the EAEU registration dossier;
- EAEC approaches to regulating the circulation of medicines;
- The prospect of changes in the rules of good practice of pharmacovigilance;
- Questions of the accelerated procedure of registration of medicines;
- Features of user testing;
- Regulatory aspects of the requirements of the EAEU legislation to the MSF as part of the registration dossier;
- Organization of the pharmacovigilance system in the countries of registration of medicines;
- Features of compliance with the instructions for medical use (IMP);
- Issues of interaction between the sponsor and the contract organization on pharmacovigilance issues;
- Features of preparation of safety reports on developed medicines (DSUR);
- Features of treatment and recall of medicines;
- Issues of preparation of instructions for medical use (IMP), general characteristics of the drug (OHL P) and leaflet (LV) for registration purposes