International Comparative Legal Guides
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Home > Law > Laws of specific jurisdictions > Legal systems: general > Civil procedure, litigation and dispute resolution > International Comparative Legal Guides: Drug & Medical Device Litigation(2 The International Comparative Legal Guide Series)
International Comparative Legal Guides: Drug & Medical Device Litigation(2 The International Comparative Legal Guide Series)

International Comparative Legal Guides: Drug & Medical Device Litigation(2 The International Comparative Legal Guide Series)


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About the Book

Welcome to the second edition of ICLG - Drug & Medical Device Litigation. Sidley Austin LLP is honoured to be the Contributing Editor of ICLG's treatise intended to provide global insight into litigation considerations critical to the life sciences industry and practitioners around the world, including from a regulatory and commercial perspective. 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.

Table of Contents:
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


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Product Details
  • ISBN-13: 9781839181092
  • Publisher: Global Legal Group Ltd
  • Publisher Imprint: Global Legal Group Ltd
  • Edition: Revised edition
  • No of Pages: 168
  • Spine Width: 6 mm
  • Width: 210 mm
  • ISBN-10: 1839181095
  • Publisher Date: 23 Apr 2021
  • Binding: Paperback
  • Height: 297 mm
  • Series Title: 2 The International Comparative Legal Guide Series
  • Sub Title: Drug & Medical Device Litigation


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