Pharmacovigilance

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For all pharmaceutical products registered within the member states of the Eurasian Economic Union (EAEU), it is a mandatory requirement to conduct comprehensive pharmacovigilance. This critical step ensures the ongoing evaluation and monitoring of the safety and efficacy of drugs, upholding the highest standards of patient care and regulatory compliance across the EAEU territories. This vigilance is integral to maintaining the trust and confidence in the pharmaceutical products circulating within these markets

Raifarm offers a comprehensive suite of pharmacovigilance services, designed to assist clients in complying with the regulatory requirements of the Russian market and those of other member states within the EAEU.

Our services include:

Local Health Authority Liaison and Pharmacovigilance Oversight: We serve as the primary point of contact for local health authorities and fulfill the role of Qualified Person for Pharmacovigilance (QPPV), including deputy responsibilities.
Management of Local Health Authority Requests: Our team expertly handles inquiries and directives from local health authorities.
Regular Reporting Commitments: We ensure timely submission of monthly pharmacovigilance reports.
Monitoring of Local Health Authority Websites: Our vigilant oversight of local health authority websites ensures up-to-date compliance with relevant guidelines and notices.
Local Literature Searches: We conduct thorough searches of local literature as part of our pharmacovigilance surveillance activities.
Processing of Local Individual Case Safety Reports (ICSRs): We manage the detailed processing of local ICSRs, ensuring accurate and timely reporting.
Submission of Periodic Safety Update Reports: Our team is adept at compiling and submitting periodic safety update reports, adhering to the required schedules and formats.
Local Risk Management Plan (RMP) Activities: We engage in activities related to local RMPs, ensuring alignment with regulatory expectations.
Medical Inquiry Management: Raifarm efficiently handles medical inquiries, providing accurate and timely responses.
Pharmacovigilance Training Programs: We offer specialized training programs in pharmacovigilance, ensuring that our clients and their teams are well-informed and compliant with current standards and practices.

Raifarm is committed to delivering exceptional pharmacovigilance services, marked by professionalism, expertise, and a deep understanding of the regulatory landscape, to ensure our clients’ success in the Russian market and other EAEU member states.

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