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Large-scale, interoperable biobanks are an increasingly important
asset in today's life science research and, as a result, multiple
types of biobanks are being established around the globe with very
different financial, organizational and legal set-ups. With
interdisciplinary chapters written by lawyers, sociologists,
doctors and biobank practitioners, Global Genes, Local Concerns
identifies and discusses the most pressing issues in contemporary
biobanking. This timely book addresses pressing questions such as:
how do national biobanks best contribute to translational
research?; What are the opportunities and challenges that current
regulations present for translational use of biobanks?; How does
inter-biobank coordination and collaboration occur on various
levels?; and how could academic and industrial exploitation,
ownership and IPR issues be addressed and facilitated? Identifying
that biobanks foundational and operational set-ups should be
legally and ethically sound, while at the same time reflecting the
hopes and concerns of all the involved stakeholders, this book
contributes to the continued development of international
biobanking by highlighting and analysing the complexities in this
important area of research. Academics in the fields of law and
ethics, health law and biomedical law, as well as biobank managers
and policymakers will find this insightful book a stimulating and
engaging read. Contributors include: T. Bossow, T.A. Caulfield,
B.J. Clark, A. Hellstadius, J.R. Herrmann, K. Hoyer, M. Jordan, J.
Kaye, N.C.H. Kongsholm, K. Liddell, J. Liddicoat, M.J. Madison, T.
Minssen, B. Murdoch, W. Nicholson Price II, E. Ortega-Paino, M.
Prictor, M.B. Rasmussen, K. Sargsyan, J. Schovsbo, A.M. Tupasela,
E. van Zimmeren, F. Vogl, H. Yu, P.K. Yu
This book addresses the growing importance of trade secrets in
today's society and business and the related increase in
litigation, media and scholarly attention. Written by a team of
international experts, it uses the new EU Trade Secrets Directive
as a prism through which to discuss the complex legal issues
involved. Featuring both EU and wider international perspectives,
chapters examine the Directive's aim of harmonizing legislation on
the protection of trade secrets across the EU, and discuss how this
has been implemented by member states. Contributors also explore
the effects of the new regime on contentious issues and crucial
sectors such as medicine, big data and AI, as well as considering
its relationship with US law in particular. Scholars and students
of patent law, innovation, and EU law and governance, particularly
those with an interest in the topic of information freedom, will
find this book of great significance in their research.
Practitioners working in trade secrets and intellectual property
more broadly will also find this book's comprehensive analysis of
the Directive and its practical implications invaluable.
Contributors include: T. Aplin, R. Arnold, N. Bruun, R. Cooper
Dreyfuss, B. Diaz Alaminos, B. Domeij, N. Lee, T. Minssen, A.
Nordberg, A. Ohly, N. Rajam, T. Riis, S.K. Sandeen, J. Schovsbo,
J.S. Sherkow, H. Udsen, B. van der Donk, M. van Eechoud
Regulators have been more permissive for medical devices compared
to their drug and biologic counterparts. While innovative products
can thereby reach consumers more quickly, this approach raises
serious public health and safety concerns. Additionally, the nature
of medical devices is rapidly changing, as software has become as
important as hardware. Regulation must keep pace with the current
developments and controversies of this technology. This volume
provides a multidisciplinary evaluation of the ethical, legal, and
regulatory concerns surrounding medical devices in the US and EU.
For medical providers, policymakers, and other stakeholders, the
book offers a framework for the opportunities and challenges on the
horizon for medical device regulation. Readers will gain a nuanced
overview of the latest developments in patient privacy and safety,
innovation, and new regulatory laws. This book is also available as
Open Access on Cambridge Core.
Regulators have been more permissive for medical devices compared
to their drug and biologic counterparts. While innovative products
can thereby reach consumers more quickly, this approach raises
serious public health and safety concerns. Additionally, the nature
of medical devices is rapidly changing, as software has become as
important as hardware. Regulation must keep pace with the current
developments and controversies of this technology. This volume
provides a multidisciplinary evaluation of the ethical, legal, and
regulatory concerns surrounding medical devices in the US and EU.
For medical providers, policymakers, and other stakeholders, the
book offers a framework for the opportunities and challenges on the
horizon for medical device regulation. Readers will gain a nuanced
overview of the latest developments in patient privacy and safety,
innovation, and new regulatory laws. This book is also available as
Open Access on Cambridge Core.
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