International Comparative Legal Guides
Global Legal Group Ltd (Verlag)
978-1-83918-109-2 (ISBN)
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In our ever-interlocking global economy, it is an imperative to understand the cutting-edge issues and legal regimes that cut across markets and legal systems. The development of life-saving medications and devices at one end of the world may carry litigation risk across the globe to manufacturers, sellers, distributors, healthcare providers and patients in other parts of the world. This Guide provides valuable information that all entities and individuals in the supply chain need to consider, including the potential ramifications of, and ways to mitigate, litigation risks.
As the times we live in illustrate, we may be physically remote but we are all connected in so many different ways via various media. Indeed, the COVID-19 crisis implicates many of the issues discussed in this treatise. Drawing on the extensive, diverse experience and knowledge of the authors worldwide, cutting across a panoply of practice areas, we explore how medications and devices are approved for marketing, regulatory processes, clinical trials, data privacy, compassionate use programmes, product recalls and litigation (and other dispute resolution proceedings), including whether there are any jurisdictional inhibitions to subjecting an entity to lawsuits in another country. We thank all of our fellow contributors for sharing their insights with us.
We hope you find this Guide to be helpful and practical as you navigate the legal challenges in the life sciences industry.
Expert Analysis Chapter
1 Challenges for ex-U.S. Entities Confronting the U.S. Regulatory and Tort Labyrinth
Alan E. Rothman, Daniel A. Spira, Teri H. Peeples & Anna-Shari Melin, Sidley Austin LLP
Q&A Chapters
10 Argentina
Beccar Varela: Emilio N. Vogelius & Ana Andres
17 Australia
Clayton Utz: Greg Williams & Alexandra Rose
25 Belarus
Sorainen: Marina Golovnitskaya, Kirill Laptev & Maria Rodich
32 Brazil
Veirano Advogados: Rosangela Delgado Barreto, Renata Fialho de Oliveira & Amanda Celli Cascaes
40 China
AllBright Law Offices: Calvin Lee
49 Cyprus
Harris Kyriakides LLC: Eleni Neoptolemou & Munevver Kasif
56 England & Wales
Addleshaw Goddard LLP: Louisa Caswell, Mark Chesher & Cecile Burgess
67 France
Winston & Strawn LLP: Gilles Bigot, Sara Susnjar, Thais Recanati & Laurine Petit
76 Germany
Bird & Bird LLP: Boris Kreye, Alexander Csaki, Christian Lindenthal & Simon Reuter
84 India
LexOrbis: Manisha Singh & Varun Sharma
92 Italy
Studio Legale Russo Valentini: Roberto Bonatti
99 New Zealand
Tompkins Wake: Tina Liu & Robert Andrew Bycroft
108 Norway
Bull & Co Advokatfirma AS: Rune Nordengen
115 Singapore
Allen & Gledhill LLP: Tham Hsu Hsien & Koh En Ying
124 Spain
Faus & Moliner Abogados: Xavier Moliner & Juan Martinez
135 Sweden
Setterwalls Advokatbyra: Helena Nilsson, Lovisa Dahl Nelson, Johan Reimer & Jonatan Blomqvist
142 Switzerland
Kellerhals Carrard: Dr. Claudia Goetz Staehelin, Dr. Oliver M. Brupbacher & Dr. Eliane Haas
152 USA
Sidley Austin LLP: Alan E. Rothman, Daniel A. Spira, Teri H. Peeples & Anna-Shari Melin
Erscheinungsdatum | 28.04.2021 |
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Reihe/Serie | The International Comparative Legal Guide Series ; 2 |
Verlagsort | London |
Sprache | englisch |
Maße | 210 x 297 mm |
Themenwelt | Recht / Steuern ► Allgemeines / Lexika |
Recht / Steuern ► EU / Internationales Recht | |
Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht | |
Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Zivilverfahrensrecht | |
Technik | |
ISBN-10 | 1-83918-109-5 / 1839181095 |
ISBN-13 | 978-1-83918-109-2 / 9781839181092 |
Zustand | Neuware |
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