scholarly journals C4C ‐ Paediatric pharmacovigilance: Methodological Considerations in Research and Development of Medicines for Children – A c4c Expert Group White Paper

2021 ◽  
Author(s):  
Beate Aurich ◽  
Dina Apele‐Freimane ◽  
Tobias Banaschewski ◽  
Laurent Chouchana ◽  
Simon Day ◽  
...  
Keyword(s):  
Research And Development ◽  
White Paper ◽  
Expert Group ◽  
Methodological Considerations ◽  
Medicines For Children

scholarly journals Emerging Trends in Virtual Reality for Gaming: an assessment of best practices from research and development in the gaming industry

2021 ◽  
Author(s):  
Daniel Harley ◽  
Jason Nolan ◽  
Anthony Walsh ◽  
Eric McQuiggan
Keyword(s):  
Virtual Reality ◽  
Best Practices ◽  
Research And Development ◽  
White Paper ◽  
Lessons Learned ◽  
Simulator Sickness ◽  
Gaming Industry ◽  
Industry Research ◽  
Emerging Trends ◽  
Player Experience

Virtual reality is a new and rapidly changing medium, with best practices still emerging at various locations across the industry. This white paper summarizes industry research and development focusing on player experience and comfort, particularly interventions that seek to mitigate the effects of Simulator Sickness. In order to better collate, evaluate and understand the variety of approaches and practices across the gaming industry, Phantom Compass partnered with the Ryerson’s Responsive Ecologies Lab to develop and playtest three prototypes that employ the current best practices in an effort examine lessons learned and expand current VR design.

scholarly journals Clinical governance in mental health services

1999 ◽  
Vol 23 (12) ◽  
pp. 711-714 ◽  
Author(s):  
Peter Kennedy
Keyword(s):  
Mental Health ◽  
National Health Service ◽  
Health Service ◽  
Research And Development ◽  
Chief Executive ◽  
Clinical Effectiveness ◽  
White Paper ◽  
Clinical Governance ◽  
The Third ◽  
Department Of Health

This is one of three articles describing how one National Health Service (NHS) trust is tackling clinical governance. The first is by the trust chief executive, the ‘accountable officer’ in the White Paper The New NHS (Department of Health, 1997). The second is by the trust's director of research and development whose responsibilities include assisting clinical directorates to carry out an annual programme of improvements in clinical effectiveness. The third paper is by the mental health lead clinician’ for clinical governance.

scholarly journals How paediatric drug development and use could benefit from OMICs: a c4c expert group white paper

2022 ◽  
Author(s):  
Eva Neumann ◽  
Filippa Schreeck ◽  
Jethro Herberg ◽  
Evelyne Jacqz Aigrain ◽  
Anke H. Maitland‐van der Zee ◽  
...  
Keyword(s):  
Drug Development ◽  
White Paper ◽  
Expert Group ◽  
Paediatric Drug ◽  
Paediatric Drug Development

scholarly journals On the Governance of Artificial Intelligence through Ethics Guidelines

2020 ◽  
pp. 1-15
Author(s):  
Stefan LARSSON
Keyword(s):  
Artificial Intelligence ◽  
White Paper ◽  
Expert Group ◽  
Policy Area ◽  
Legal Perspective ◽  
China And Japan ◽  
Ethics Guidelines ◽  
High Level ◽  
Eu Commission ◽  
The Eu

Abstract This article uses a socio-legal perspective to analyze the use of ethics guidelines as a governance tool in the development and use of artificial intelligence (AI). This has become a central policy area in several large jurisdictions, including China and Japan, as well as the EU, focused on here. Particular emphasis in this article is placed on the Ethics Guidelines for Trustworthy AI published by the EU Commission’s High-Level Expert Group on Artificial Intelligence in April 2019, as well as the White Paper on AI, published by the EU Commission in February 2020. The guidelines are reflected against partially overlapping and already-existing legislation as well as the ephemeral concept construct surrounding AI as such. The article concludes by pointing to (1) the challenges of a temporal discrepancy between technological and legal change, (2) the need for moving from principle to process in the governance of AI, and (3) the multidisciplinary needs in the study of contemporary applications of data-dependent AI.

scholarly journals Current knowledge, challenges and innovations in developmental pharmacology: a combined c4c expert group and ESDPPP White paper

2021 ◽  
Author(s):  
Anne Smits ◽  
Pieter Annaert ◽  
Giacomo Cavallaro ◽  
Pieter A. J. G. De Cock ◽  
Saskia N. Wildt ◽  
...  
Keyword(s):  
Current Knowledge ◽  
White Paper ◽  
Expert Group ◽  
Developmental Pharmacology

scholarly journals C4C - Paediatric pharmacovigilance: Methodological Considerations in Research and Development of Medicines for Children – A c4c Expert Group White Paper

2021 ◽  
Author(s):  
Beate Aurich ◽  
Dina Apele-Freimane ◽  
Tobias Banaschewski ◽  
Laurent Chouchana ◽  
Simon Day ◽  
...  
Keyword(s):  
Life Cycle ◽  
Data Collection ◽  
Safety Data ◽  
Expert Group ◽  
Medicinal Products ◽  
Paediatric Drug ◽  
Protocol Development ◽  
Spontaneous Reports ◽  
Data Collection And Analysis ◽  
Methodological Considerations

Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regards to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population specific factors (e.g. more frequent use of off-label/unlicensed drugs). In recognition of these challenges a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life-cycle of medicinal products which is described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development and safety data collection and analysis. Furthermore, they describe the specific details of post-marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record-linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit-risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life-cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a c4c expert group White paper

2021 ◽  
Author(s):  
Jennifer Walsh ◽  
Daniel Schaufelberger ◽  
Sonia Iurian ◽  
Sandra Klein ◽  
Hannah Batchelor ◽  
...  
Keyword(s):  
White Paper ◽  
Expert Group ◽  
Formulation Development ◽  
Paediatric Formulation

scholarly journals Emerging Trends in Virtual Reality for Gaming: an assessment of best practices from research and development in the gaming industry

2021 ◽  
Author(s):  
Daniel Harley ◽  
Jason Nolan ◽  
Anthony Walsh ◽  
Eric McQuiggan
Keyword(s):  
Virtual Reality ◽  
Best Practices ◽  
Research And Development ◽  
White Paper ◽  
Lessons Learned ◽  
Simulator Sickness ◽  
Gaming Industry ◽  
Industry Research ◽  
Emerging Trends ◽  
Player Experience

Virtual reality is a new and rapidly changing medium, with best practices still emerging at various locations across the industry. This white paper summarizes industry research and development focusing on player experience and comfort, particularly interventions that seek to mitigate the effects of Simulator Sickness. In order to better collate, evaluate and understand the variety of approaches and practices across the gaming industry, Phantom Compass partnered with the Ryerson’s Responsive Ecologies Lab to develop and playtest three prototypes that employ the current best practices in an effort examine lessons learned and expand current VR design.

scholarly journals Schumpeterian Entrepreneurship Revisited: Historical Specificity and the Phases of Capitalist Development

2006 ◽  
Vol 28 (3) ◽  
pp. 315-332 ◽  
Author(s):  
Alexander Ebner
Keyword(s):  
Economic Development ◽  
Research And Development ◽  
Early Model ◽  
Capitalist Development ◽  
Late Model ◽  
Theoretical Reasoning ◽  
Historical Specificity ◽  
Methodological Considerations ◽  
Schumpeterian Approach

Schumpeter's theory of entrepreneurship and innovation has been repeatedly interpreted in terms of a conceptual dualism, shifting from an early model of personal entrepreneurship in newly founded enterprises to a late model of research and development in large enterprises, responding to changes in the productive organization of capitalism. Due to theoretical inconsistencies, Schumpeter thus seemingly altered his argument on the role of entrepreneurship in economic development (Freeman et al. 1982, pp. 41–42). In countering these allegations, it has been put forward that Schumpeter's instrumental methodology would allow for settling historical experiences and theoretical reasoning on different analytical levels. Accordingly, the substantial validity of the Schumpeterian approach would remain independent from variable historical settings (Frank 1998, pp. 505–506). Adding to these methodological considerations, it has been suggested that the consistency of Schumpeter's argument could be reconstructed in terms of an explanation of capitalist development that resonates Weberian thought on rationalization and bureaucratization (Langlois 1998b, pp. 57–58).

scholarly journals Análisis de la propuesta de Reglamento sobre los principios éticos para el desarrollo, el despliegue y el uso de la inteligencia artificial, la robótica y las tecnologías conexas.

2020 ◽  
Vol 6 (2) ◽  
pp. 26-41
Author(s):  
Guillermo Lazcoz Moratinos
Keyword(s):  
Artificial Intelligence ◽  
European Commission ◽  
White Paper ◽  
Soft Law ◽  
Expert Group ◽  
Ethical Guidelines ◽  
General Application ◽  
Legislative Proposal ◽  
Constructive Criticism ◽  
High Level

On 20 October 2020, the European Parliament adopted a resolution (2020/2012(INL)) with recommendations to the Commission regarding artificial intelligence, robotics and related technologies, which included a legislative proposal for a Regulation on the ethical principles for the development, deployment and use of these technologies. The content of this proposal undoubtedly follows from the regulatory vision that the European Commission has maintained in documents such as the White Paper on Artificial Intelligence (COM(2020) 65 final) or the Ethical guidelines for trustworthy AI drawn up by the High-Level Expert Group on AI. Given this new legislative horizon, it is more necessary than ever to address a constructive criticism on the proposal, highlighting the possibility of reformulating its markedly soft-law character despite its location in a regulatory source of general application and directly applicable, such as regulations, or the adopted approach for certain key principles such as human supervision or discrimination.

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