Press Release: Second Regulatory Roundtable
28th May 2021
The Women’s Brain Project’s second regulatory roundtable builds the momentum to ensure that sex and gender-based precision medicine becomes a reality
“Our goal was to promote a change in the regulatory space at the international level.” Antonella Chadha Santuccione, CEO of the Women’s Brain Project, says. “And promoting gender health equity to make healthcare systems more sustainable”
In September 2020 the Women’s Brain Project held a landmark regulatory roundtable on advancing sex and gender precision medicine.
This initial regulatory roundtable brought together key regulators and other stakeholders to learn from the experience of the U.S. Food and Drug Administration (FDA), which has a dedicated Office of Women’s Health (OWH), and to see how they could further prioritise women’s health, sex and gender medicine, and diversity issues in other regulatory agencies.
The Women’s Brain Project’s follow-up regulatory roundtable, which was held virtually on the 27 May 2021, discussed further actions, to address critical gaps in gender equity in health research. Participants touched upon key issues that need to be tackled from the unestablished knowledge base, approved therapies that are under-analysed, underappreciated impact to lack of awareness. The need to involve all stakeholders, and in particular, ensure that the patient voice is heard was strongly emphasised.
“The pandemic has demonstrated the relevance of sex and gender differences in drug development, in terms of drug safety and efficacy.” says Maria Teresa Ferretti, Chief Scientific Officer of the Women’s Brain Project “This initiative led by the WBP is a much-needed step towards implementing sex and gender-based precision medicine.”
The purpose of the roundtable was to create a high-level working group that can advance the debate on sex and gender considerations in the regulatory space. This event brought together key regulators, such as, the European Medicines Agency (EMA), Health Canada, the U.S. Food and Drug Administration (FDA) and other stakeholders to promote change in the regulatory space at the international level and to promote sex and gender-specific measures in clinical trials, drug development and policy at large.
Annemarie Schumacher Dimech, President of the Women’s Brain Project, says “We look forward to continuing this discussion at the third roundtable planned for Autumn 2021 and to working together on tangible results for effective and sustainable drug development taking into consideration individual characteristics.”
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