Let us help you navigate EudraVigilance reporting requirements

Effective 30 June 2022, EudraVigilance users are required to file individual case safety reports (ICSRs) using the ISO ICSR/ICH E2B (R3) format and related ISO standard terminology for pharmaceutical form and route of administration.

While technically challenging for some stakeholders, this change is an opportunity to obtain better insights into ICSRs and the benefit-risk profile of medicinal products.

Med Communications has a global pharmacovigilance team ready to serve your company’s needs, including assistance with filing ICSRs. Physicians, pharmacists, nurses, and other health care professionals are fully trained in all aspects of pharmacovigilance and provide outstanding support. Contact us at 877-477-0977 or to learn more about how we can help you with your reporting needs.

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