ISoP Symposium & Training for Eurasia 2021

10-11 & 18-19 June | Webinar

Co-ordinator: Jean-Christophe Delumeau (ISoP Executive member).

The societal importance of pharmacovigilance in Eurasia

Organized according to the Plan of Scientific and Practical Events of the Ministry of Healthcare of the Russian Federation, jointly by the Federal Service for Surveillance in Healthcare and the Russian Medical Academy of Continuous Professional Education.

This Symposium and Training was the first of its kind organised by ISoP for Healthcare Professionals involved in ensuring the safe use of medicines in the Eurasian Economic Union (EAEU) and other countries of the Eurasian area. The driving theme of this event was the Societal Importance of Pharmacovigilance in Eurasia and aimed to make all stakeholders better aware of the need to promote the behaviours leading to improved adverse event reporting.

This event was occurring at the crucial time of a significant update of the EAEU Good Vigilance Practices. These practices are designed to prioritise pharmacovigilance activities in proportion to safety risks, implement consistency across National Regulatory Authorities, while utilising advanced analytic methods to safety data.

This event was conducted online on June 4 and 5, then June 18 and 19. Each of those four days was composed of 3 sessions of 90 minutes each with separated by 30-minute intermissions for relaxing. Overall, it provided 12 hours of presentations and 6 hours of panel discussions.

This webinar aimed to engage all interested pharmacovigilance professionals in an industry, regulatory, or university setting.

Training certificates were provided by e-mail to those who complete the training.

The following themes were developed during this Symposium & Training. Presentations were given by speakers from the EAEU or by International Experts member of ISoP or appointed especially. English-Russian and Russian-English simultaneous translation were provided.

Overview

June 4	Committing HCPs and the Society to the Importance of Pharmacovigilance
Session 1A	The societal importance of pharmacovigilance in Eurasia
Session 1B	HCP’s and Patients commitment to the safe use of medicines
Session 1C	Improving the Safety Regulatory Framework in Eurasia

June 5	Medical Aspects of Pharmacovigilance
Session 2A	Pharmacovigilance of vaccines
Session 2B	Medical pharmacovigilance
Session 2C	Clinical pharmacovigilance

June 18	Methods in Pharmacovigilance and Risk Minimisation
Session 3A	Collecting and managing post-authorisation safety data
Session 3B	Detection and management of safety signals
Session 3C	Risk minimisation and safety communications methods

June 19	Audits and Inspections
Session 4A	Audits and Inspections: Rationale, Principles and legislations
Session 4B	Preparing, conducting and experiencing Audits and Inspections
Session 4C	Managing Corrective and Preventive Actions (CAPA) followed by Event wrap-up

Programme