Expertise · Pharmacovigilance

EAEU Pharmacovigilance for Foreign Marketing Authorization Holders: Vendor Selection, PSMF, RMP and Sponsor Oversight

PSMF, RMP, local vendors and sponsor oversight

Pharegis supports EAEU pharmacovigilance operating models for foreign marketing authorization holders, including local vendor governance, PSMF and RMP interfaces, safety information flow and sponsor oversight.

Current guidance is consolidated in the EAEU pharmacovigilance article.

EAEU pharmacovigilance safety systems, vendor oversight and governance
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