Pharmacovigilance
Since 2022, SOLOREG offers a full range of services in the field of pre-registration and post-marketing pharmacovigilance that comply with the requirements of the Good Pharmacovigilance Practice Rules of the EAEU:
• Organization of a 24-hour hotline
• Conducting pharmacovigilance trainings
• Processing individual reports of adverse reactions in Russia (signal management, collection, validation, medical assessment, reporting)
• Maintenance of a database of individual reports of adverse reactions to medicinal products (IADR)
• Screening of safety reports
• Preparation and submission of periodic safety reports to regulatory authorities
• Monitoring the benefit-risk ratio
• Development of risk management plans