Landmark Regulatory Roundtable on advancing women’s health and precision medicine

By Anna Dé, Executive Committee member of WBP

 

On 17 September 2020, the Women’s Brain Project (WBP) held a landmark regulatory roundtable on advancing sex and gender precision medicine.

egulatory 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 we can further prioritise women’s health, sex and gender medicine, and diversity issues in other regulatory agencies.

The roundtable was an invitation-only event, and was held under the Chatham House Rule. In the spirit of the rule, we cannot disclose who said what, but we have put together the key takeaways of the meeting here in this document.

WBP hopes that this will be the first of many global stakeholder interactions to advance women’s health in the research, development, evaluation, and approval of medicines. All marches start with a first step, and we think that the world should come together to advance women’s health and precision medicine. This will involve all relevant stakeholders coming together in a multi-stakeholder and multidisciplinary approach.

We plan to hold a follow-up regulatory roundtable in Q1 2021 to discuss further actions, such as the idea to take the concept of the FDA’s Women’s Health Research Roadmap globally. WBP will also continue in its mission to create a sex and gender precision medicine research institute.

We call upon all relevant stakeholders to join us in our efforts to further the momentum on sex and gender precision medicine. For more information or to get involved, reach out to info[at]womensbrainproject.com.