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1 . Academic Journal
Collaboration for new therapies: maximizing health and innovation
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by
Jorge Mestre-Ferrandiz
;
Pierre Meulien
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Dennis A. Ostwald
;
Virginia Acha
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Frontiers in Public Health, Vol 12 (2024)
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6 . Academic Journal
Real‐world evidence to support regulatory submissions: A landscape review and assessment of use cases
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by
Golnoosh Alipour‐Haris
;
Xinyue Liu
;
Virginia Acha
;
Almut G. Winterstein
;
Mehmet Burcu
.
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Clinical and Translational Science, Vol 17, Iss 8, Pp n/a-n/a (2024)
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7 . Academic Journal
Breaking up the band: European regulatory cooperation in a post-Brexit world
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Virginia Acha
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British Journal of Pharmacy, Vol 2, Iss 1 (2017)
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3 .
The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries
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by
Kevin Klein
;
Mümün Gencoglu
;
Jens Heisterberg
;
Virginia Acha
;
Pieter Stolk
.
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BioDrugs
. 37:235-245
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7 .
Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014
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by
Nathalie Lambot
;
Jacquelyn Awigena-Cook
;
Tatiana Reimer
;
Annelie Persson
;
Julien Romanetto
, et al.
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Cell and Gene Therapy Insights
. 7:1093-1106
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7 .
Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective
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by
Inkatuuli Heikkinen
;
Sini Eskola
;
Virginia Acha
;
Alan Morrison
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Chris Walker
, et al.
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Drug Discovery Today
. 28:103526
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7 .
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines
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by
Agnese Cangini
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Maren Koban
;
Leonor Varela Lema
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Spiros Vamvakas
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Deborah Morrison
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British Journal of Clinical Pharmacology
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7 .
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?
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by
Kevin Klein
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Pieter Stolk
;
Pär Tellner
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Virginia Acha
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Sarah Montagne
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Therapeutic innovationregulatory science
. 56(2)
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7 .
Translating European regulatory approval into healthcare uptake for biosimilars: the second translational gap
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Jorge Mestre-Ferrandiz
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Virginia Acha
.
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Technology Analysis & Strategic Management
. 29:263-275
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4 .
A Financial Accounting based Model of Carbon Footprinting: Built Environment Example
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by
Alex Veys
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Sandro Macchietto
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Virginia Acha
.
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