Druedahl, Louise C. http://orcid.org/0000-0002-8979-8666
Almarsdóttir, Anna Birna
Kälvemark Sporrong, Sofia http://orcid.org/0000-0001-5848-8625
De Bruin, Marie Louise http://orcid.org/0000-0001-9197-7068
Hoogland, Hans
Minssen, Timo http://orcid.org/0000-0002-3286-4888
van de Weert, Marco
Kesselheim, Aaron S.
Sarpatwari, Ameet http://orcid.org/0000-0001-5043-6206
Article History
First Online: 3 November 2020
Competing interests
: LEO Pharma A/S was aware of but had no decisive role in the design or conduct of the study, collection, management, analysis or interpretation of data, or the decision to submit the manuscript for publication. M.L.D.B. is an employee of the Copenhagen Centre for Regulatory Sciences (CORS). CORS is a cross-faculty university-anchored institution involving various public (Danish Medicines Agency Copenhagen University) and private (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) stakeholders, as well as patient organizations (Rare Diseases Denmark). The center is devoted to the scientific aspects of the regulatory field with a patient-oriented focus; its research is not company or product-specific; and it has received funding from LEO Pharma A/S for this project, as well as from Novo Nordisk, Ferring Pharmaceuticals and Lundbeck for other projects not related to this study. T.M. is a part-time senior advisor at X-officio. X-officio is a consulting firm that supports departments of administration, COOs, DG/CEOs and national ministries in all matters pertaining to legal, governance and procurement in the process of establishing, constructing and operating a research infrastructure. X-officio also advises companies and supports business and contractual partners in legal and procurement matters.
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