Co-ordinators: Jean-Christophe Delumeau (ISoP Executive member) and Sergei Glagolev (Head of the National Pharmacovigilance Centre of Russia, Roszdravnadzor)

This Symposium and Training is the first event of this kind organised by ISoP in the Russian Federation. It is intended to address the needs of the different stakeholders from the Eurasian Economic Union (EAEU) interested in the large array of pharmacovigilance (PV) methods and activities.

The 2020 ISoP Symposium & Training will be happening at a crucial time for the EAEU region. After implementing a common Good Vigilance Practice several years ago, the PV systems of the respective EAEU countries, are moving toward maturity but at different speed. There is also a need to move forward together with updated International regulations. To address those issues, a revision of the EAEU-GVP is underway.

This 3-day event will include two days (September 23-24) of symposium and training course on pharmacovigilance topics of interest for all health care professionals, followed on September 25 by a day of Training and Workshops intended for Regulators and healthcare industry/CRO professionals involved in pharmacovigilance activities (Workshop-A: Systems for case management and signal detection; Workshop-B on Audit and Inspection). Overall, the event will include 4 panel discussions interacting with the Audience, a practicum on benefit vs risk evaluation and risk minimisation decisions making, and a Practicum intended for Regulators on the use of VigiLyze for signal detection.

The programme will cover topics such as:
• The societal importance of pharmacovigilance
• Pharmacovigilance systems in Russia and other Eurasian countries
• EAEU-GVP implementation experience and upcoming changes
• Severe Cutaneous Adverse Reactions (SCARs)
• Safety of oncology medicines
• Postmarketing surveillance of biologics in the biosimilar era.
• Patient involvement in the development and safe use of medicines
• Individual Case Safety Reports (ICSRs) concepts and management
• Signal detection and management: Principles and methods
• Safety specifications of medicines and their benefit vs risk evaluation
• Risk Management planning: pharmacovigilance and risk minimisation methods
• Systems for ICSR management and signal detection
• E2B(R3) database systems: Russian vs Global experience
• Use of artificial intelligence, machine learning and other advance technologies
• Audit and Inspection in Pharmacovigilance.

At the end of this Symposium & Training, participants are expected to have acquired an overall understanding of pharmacovigilance systems, principles, concepts and practices according to internationally agreed standards and to be capable of promoting those practices in their respective environment.
The faculty for this course consists of international and national experts in pharmacovigilance, representing government, academia, and industry.