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Hemophilia is a rare heredity bleeding disorder that requires treatment for life. While few therapeutic options were available in the past, multiple recent breakthroughs have fundamentally altered and diversified hemophilia therapy, with even more new therapeutic options forthcoming. These changes are mirrored by significant regulatory and legal changes, which have redefined the role of hemophilia registries in the European Union (EU). This dual paradigm shift poses new regulatory, scientific but also structural requirements for hemophilia registries. The aim of this manuscript is to enumerate these significant challenges and to demonstrate their incorporation into the redesign of the German Hemophilia Registry (Deutsches Hämophilieregister, dhr). To identify the spectrum of hemophilia therapies and the degree of regulatory changes, a horizon screening was performed. Consequently, a core dataset for the dhr was defined by harmonization with regulatory guidelines as well as other hemophilia registries and by heeding the needs of different stakeholders (patients, clinicians, regulators, and scientists). Based on this information, a new registry structure was established, which is optimized for capturing data on new and established hemophilia therapies in a changing therapeutic and regulatory landscape

Hemophilia is a rare heredity bleeding disorder that requires treatment for life. While few therapeutic options were available in the past, multiple recent breakthroughs have fundamentally altered and diversified hemophilia therapy, with even more new therapeutic options forthcoming. These changes are mirrored by significant regulatory and legal changes, which have redefined the role of hemophilia registries in the European Union (EU). This dual paradigm shift poses new regulatory, scientific but also structural requirements for hemophilia registries. The aim of this manuscript is to enumerate these significant challenges and to demonstrate their incorporation into the redesign of the German Hemophilia Registry (Deutsches Hämophilieregister, dhr). To identify the spectrum of hemophilia therapies and the degree of regulatory changes, a horizon screening was performed. Consequently, a core dataset for the dhr was defined by harmonization with regulatory guidelines as well as other hemophilia registries and by heeding the needs of different stakeholders (patients, clinicians, regulators, and scientists). Based on this information, a new registry structure was established, which is optimized for capturing data on new and established hemophilia therapies in a changing therapeutic and regulatory landscape.

In March 2019, German-speaking scientists and scholars calling themselves Scientists for Future, published a statement in support of the youth protesters in Germany, Austria, and Switzerland (Fridays for Future, Klimastreik/Climate Strike), verifying the scientific evidence that the youth protestors refer to. In this article, they provide the full text of the statement, including the list of supporting facts (in both English and German) as well as an analysis of the results and impacts of the statement. Furthermore, they reflect on the challenges for scientists and scholars who feel a dual responsibility: on the one hand, to remain independent and politically neutral, and, on the other hand, to inform and warn societies of the dangers that lie ahead.

In March 2019, German-speaking scientists and scholars calling themselves Scientists for Future, published a statement in support of the youth protesters in Germany, Austria, and Switzerland (Fridays for Future, Klimastreik/Climate Strike), verifying the scientific evidence that the youth protestors refer to. In this article, they provide the full text of the statement, including the list of supporting facts (in both English and German) as well as an analysis of the results and impacts of the statement. Furthermore, they reflect on the challenges for scientists and scholars who feel a dual responsibility: on the one hand, to remain independent and politically neutral, and, on the other hand, to inform and warn societies of the dangers that lie ahead. ; ISSN:0940-5550

In March 2019, German-speaking scientists and scholars calling themselves Scientists for Future, published a statement in support of the youth protesters in Germany, Austria, and Switzerland (Fridays for Future, Klimastreik/Climate Strike), verifying the scientific evidence that the youth protestors refer to. In this article, they provide the full text of the statement, including the list of supporting facts (in both English and German) as well as an analysis of the results and impacts of the statement. Furthermore, they reflect on the challenges for scientists and scholars who feel a dual responsibility: on the one hand, to remain independent and politically neutral, and, on the other hand, to inform and warn societies of the dangers that lie ahead. © 2019 G. Hagedorn et al.; licensee oekom verlag.This Open Access article is published under the terms of the Creative Commons Attribution License CCBY4.0 (http://creativecommons.org/licenses/by/4.0).