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Newsletter December 2025 | ||||||
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Dear Subscriber, Welcome to the tenth edition of the Real4Reg’s newsletter! Furthermore, you’ll be able to find news about our next Experts Workshop, information regarding Real4Reg’s last Consortium Meeting of 2025 and participation in scientific events in November. Lastly, you will also be able to stay informed about upcoming events. | ||||||
Bridging the Gender Gap in Healthcare: The Transformative Potential of RWE and AI for Women's Safety and Access to MedicinesHistorically, women have been underrepresented in clinical trials due to concerns over potential impacts on reproductive health or due to perceived hormonal variability complicating study results. This has resulted in a critical lack of data on how conditions manifest differently in women or how pharmaceuticals behave in female physiology. Consequently, medicinal products and drug dosages are typically optimised for male subjects, leading to poorer health outcomes and a higher incidence of adverse drug reactions (ADRs) in women. The historical exclusion of women from clinical trials has created a pervasive gender gap in medical knowledge, leading to a healthcare system built around the "male as default" model. However, the advent of real-world data (RWD), real-world evidence (RWE), and advanced artificial intelligence (AI) provides an unprecedented opportunity to address these systemic issues, dramatically improving patient safety, increasing access to appropriate medicines, and closing the long-standing equity gap for women. Sections in this issue:
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Partner presentation: European Institute of Women’s
Health (EIWH)
The European Institute of Women’s Health (EIWH) is a pan-European non-governmental organisation dedicated to advancing gender equity in health through research, policy engagement, and advocacy. For more than twenty-five years, EIWH has worked to ensure that sex and gender considerations are systematically integrated into health research, clinical practice, and health policy across Europe. Guided by scientific evidence and public health principles, the EIWH collaborates with European Union (EU) institutions, national governments, researchers, and civil society to improve health outcomes for women and girls throughout the life course. AimsThe central mission of the EIWH is to close persistent health gender gaps by ensuring that women’s specific needs are recognised, researched, and addressed. EIWH promotes the collection and use of sex- and gender-disaggregated data, advocates for inclusive and representative clinical trials, and raises awareness of gendered health determinants. The organisation also works to strengthen evidence on medicine safety during pregnancy and to highlight priority areas such as cardiovascular disease, mental health, menopause, ageing, and the impact of unpaid care work. Through its policy work and partnerships at EU and international levels, EIWH supports the development of more equitable health systems and contributes to shaping regulations, funding programmes, and research agendas that affect women’s health across Europe. EIWH actively participates in expert groups such as the Patients’ and Consumers’ Working Party (PCWP) at the European Medicines Agency (EMA) and the Advisory Forum at the European Centre for Disease Prevention and Control (ECDC) and collaborates with stakeholders to promote gender-sensitive health innovation, including in digital health and AI intelligence, where the risk of replicating existing biases remains significant. Expertise and ActivitiesThe EIWH brings deep multidisciplinary expertise in gender, health policy, biomedicine, public health, and health equity. Its work includes:
The organisation also disseminates data and research findings, engages in multi-stakeholder dialogue, and develops strategic roadmaps for improving women’s health outcomes across the life span. Its 2024 Women’s Health Manifesto and contributions as coo-secretariat for the Members of the European Parliament (MEPs) for Women’s Health Interest Group reflect its leadership role in setting a clear vision for gender-equitable health policy in Europe. Role in Real4RegWithin the Real4Reg project, the EIWH contributes with its
long-standing expertise on sex and gender in health research to
support the development of more inclusive, representative, and
equitable evidence-generation practices. The organisation raises
awareness of structural gaps—such as the historical
underrepresentation of women in clinical trials and the importance
of sex- and gender-disaggregated data—that have direct implications
for RWE and regulatory decision-making.
European Institute of Women’s Health (EIWH) in media
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News | ||||||
Experts Workshop – Save the DateReal4Reg will host an Online Experts Workshop on 27 January 2026 entitled “Real4Reg Use Case 1 – Lessons Learned on Exploring Real-World Data”. This event will focus on data science aspects of Use Case 1, showcasing results from breast cancer and amyotrophic lateral sclerosis analysis, the implementation of the common data model Observational Medical Outcomes Partnership (OMOP), among other topics. A roundtable discussion with different stakeholders, such as HTA, regulatory, academia, industry and patient organisations, will foster engaging exchanges. The registrations are already open and we look forward to receiving you.
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Last 2025 Consortium MeetingOn 17 November, Real4Reg had the last Consortium Meeting of the year, where the recent updates and results from the project were shared between the members. Furthermore, we had the pleasure of having present our esteemed Advisory Board as well as Prof. Dr. Olaf Klungel (Utrecht University), who provided a keynote speech on “Use of Real-World Data in Regulatory Decision-Making on Medicines”. Their presence greatly contributed to insightful discussions and enriched the exchange of ideas among all participants. | ||||||
Participation in Scientific Events in NovemberLast month, Real4Reg’s goals and achieved results were shared with multiple stakeholders in various conferences across Europe:
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Upcoming Events27 January, Online 27-28 January, Helsinki, Finland 11-13 February, Hoofddorp,
Netherlands For more information on additional events in the realms of RWE, AI, and health, please consult our Events page. | ||||||
Follow Real4Reg on Social Media
RealReg is a project funded by the European Union under the Horizon Europe programme –Project No. 101095353. The consortium of ten European institutions aims to promote the use of real-world data to support regulatory decisions about medicines. For media inquiries, please contact: real4reg@infarmed.pt Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the granting authority can be held responsible for them. | ||||||
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ImprintFederal Institute for Drugs and Medical Devices
(BfArM) Headquarters Bonn: Headquarters Cologne: Phone: +49 (0)228 99 307-0 If you don't want to receive this mailing anymore, you can unsubscribe with your email adress here: unsubscribe link. |
