Search Results - "Eskola, Sini"

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018–2019 by Eskola, Sini M., Leufkens, Hubertus G.M., Bate, Andrew, De Bruin, Marie Louise, Gardarsdottir, Helga

“…Use of Real-World Data (RWD) has gained the interest of different stakeholders in cancer care. The aim of this study was to identify and describe the use of…”
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Repurposing of Medicines in the EU: Launch of a Pilot Framework by Asker-Hagelberg, Charlotte, Boran, Tomas, Bouygues, Christelle, Eskola, Sini Marika, Helmle, Laszlo, Hernández, César, Houýez, François, Lee, Helen, Lingri, Dimitra D, Louette, Laurent, Meheus, Lydie, Penninckx, Wim, Stepniewska, Beata

“…Repurposing of authorised medicines has been under discussion for a long time. Drug repurposing is the process of identifying a new use for an existing…”
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New features of the pharmacovigilance legislation and their impact on pharmaceutical industry by Eskola, Sini

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Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019 by Eskola, Sini Marika, Leufkens, Hubertus Gerardus Maria, Bate, Andrew, De Bruin, Marie Louise, Gardarsdottir, Helga

“…Real‐world data/real‐world evidence (RWD/RWE) are considered to have a great potential to complement, in some cases, replace the evidence generated through…”
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Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective by Heikkinen, Inkatuuli, Eskola, Sini, Acha, Virginia, Morrison, Alan, Walker, Chris, Weil, Catherine, Bril, Antoine, Wegner, Max, Metcalfe, Thomas, Chibout, Salah-Dine, Chlebus, Magda

“…•Pharmaceutical legislation is an important modulator of the pharmaceutical innovation system.•The legislation has evolved in the past 20 years into a complex…”
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