October 1, 2026 - 13:13

Emer Cooke, the Executive Director of the European Medicines Agency, addressed a multi-stakeholder workshop focused on women's health, outlining the agency's commitment to closing long-standing gaps in care and treatment. During her remarks, Cooke explained how the EMA is working to ensure that medicines and medical devices are evaluated with women's specific needs in mind, from clinical trial design through to post-authorization monitoring.
She noted that women have historically been underrepresented in certain research areas, which has led to gaps in data on how some treatments affect them. Cooke pointed to ongoing efforts to encourage more inclusive trial populations and to strengthen the collection of sex-disaggregated data so that regulators, clinicians, and patients can make better informed decisions.
The workshop brought together patient groups, healthcare professionals, researchers, and industry representatives to discuss practical steps for improving women's health outcomes. Topics included conditions that disproportionately affect women, such as endometriosis, menopause-related issues, and cardiovascular disease, which is sometimes overlooked in female patients.
Cooke stressed that collaboration across sectors is essential. She said the EMA will continue to engage with stakeholders to make sure women's health remains a priority in regulatory science and that the benefits of new treatments reach all patients who need them. The agency plans to build on these discussions through further workshops and follow-up initiatives in the coming months.
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