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Marisa Papaluca-Amati
European Medicines Agency
11Publications
6H-index
325Citations
Publications 11
Newest
#1Philip A. Hines (European Medicines Agency)H-Index: 1
#2Richard H. Guy (University of Bath)H-Index: 78
Last.Marisa Papaluca-Amati (European Medicines Agency)H-Index: 6
view all 5 authors...
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#1Philip A. Hines (European Medicines Agency)H-Index: 1
#2Richard H. GuyH-Index: 78
Last.Marisa Papaluca-Amati (European Medicines Agency)H-Index: 6
view all 4 authors...
It is increasingly important that regulatory agencies catalyse the translation of scientific and technological innovation into improved patient-centred health care. Here, we highlight the strategic goals of the European Medicines Agency to advance regulatory science and optimize the opportunities arising in areas such as cell and gene therapies, big data and artificial intelligence. It is increasingly important that regulatory agencies catalyse the translation of scientific and technological inn...
2 CitationsSource
#1Philip A. HinesH-Index: 1
Last.Marisa Papaluca-Amati (European Medicines Agency)H-Index: 6
view all 5 authors...
Objectives Society is confronted with the rapid emergence of innovation in science and technology. To manage this, horizon scanning is being adopted globally to identify, assess and prioritise innovations and trends at an early stage of their development. This enables decision-makers to be better informed and to prepare for change. The aim of this paper is to systematically identify and evaluate horizon scanning methodologies employed in the healthcare and biomedical fields. Methods A systematic...
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#1Olivier Collignon (European Medicines Agency)H-Index: 2
#2Franz Koenig (Medical University of Vienna)H-Index: 19
Last.Martin Posch (Medical University of Vienna)H-Index: 39
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Background In recent years, experience on the application of adaptive designs in confirmatory clinical trials has accumulated. Although planning such trials comes at the cost of additional operational complexity, adaptive designs offer the benefit of flexibility to update trial design and objectives as data accrue. In 2007, the European Medicines Agency (EMA) provided guidance on confirmatory clinical trials with adaptive (or flexible) designs. In order to better understand how adaptive trials a...
2 CitationsSource
#1Falk Ehmann (European Medicines Agency)H-Index: 11
#2Laura Caneva (European Medicines Agency)H-Index: 2
Last.Marisa Papaluca-Amati (European Medicines Agency)H-Index: 6
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Pharmacogenomics (PGx) has a growing impact on healthcare and constitutes one of the major pillars of personalised medicine. For the purpose of improved individualised drug treatment, there is an increasing effort to develop drugs suitable for specific subpopulations and to incorporate pharmacogenomic drug labels in existing and novel medicines. Here, we review the pharmacogenomic drug labels of all 517 medicinal products centrally approved in the European Union (EU) since the establishment of t...
61 CitationsSource
#1Amelie ElsäßerH-Index: 1
#2Jan Regnstrom (European Medicines Agency)H-Index: 4
Last.Martin Posch (Medical University of Vienna)H-Index: 39
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Background Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug Administration (FDA) have published guidance documents addressing the potentials and limitations of adaptive designs in the regulatory context. Since there is limited experience in the implementation an...
44 CitationsSource
#1Laura Caneva (European Medicines Agency)H-Index: 2
#2Milton Bonelli (European Medicines Agency)H-Index: 3
Last.Jean-Marc Vidal (European Medicines Agency)H-Index: 4
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Abstract In this article we analyse the Environmental Risk Assessment (ERA) of 59 medicinal products for human use authorised in the EU through the centralised procedure between 2011 and 2012, to establish whether company submissions are compliant with the European Medicines Agency (EMA) guideline and complete in terms of data and study reports provided. The most frequent questions raised by EU regulatory authorities are described, together with an evaluation of the presence and quality of ERA-r...
2 CitationsSource
#1Francesco PignattiH-Index: 18
#2Falk EhmannH-Index: 1
Last.Guido RasiH-Index: 32
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The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important propos...
30 CitationsSource
#1Linda C SurhH-Index: 1
Last.Nadine A CohenH-Index: 1
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The 2010 US FDA–Drug Industry Association (DIA) Pharmacogenomics (PGx) Workshop follows a series that began in 2002 bringing together multidisciplinary experts spanning regulatory authorities, medical research, healthcare and industry. This report summarizes the ‘Building PGx into Labels’ sessions from the workshop, which discussed the critical elements in developing PGx outcomes leading to product labels that inform efficacy and/or safety. Examples were drawn from US prescribing information, wh...
20 CitationsSource
#1Federico Goodsaid (CDER: Center for Drug Evaluation and Research)H-Index: 29
#2Shashi Amur (CDER: Center for Drug Evaluation and Research)H-Index: 18
Last.Issam Zineh (CDER: Center for Drug Evaluation and Research)H-Index: 19
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Biomarker strategies are increasingly being applied in drug development to address the challenges posed by heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US FDA initiated a programme in 2004 to allow sponsors to submit exploratory data voluntarily, without immediate regulatory impact. This article discusses...
80 CitationsSource
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