The Life Sciences Law Review - Edition 4

Richard Kingham
  • Editor:
  • Richard Kingham
  • Covington & Burling LLP

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The fourth edition of The Life Sciences Law Review provides an overview of legal issues of interest to pharmaceutical, biotechnology and medical device companies in more than 30 jurisdictions. As before, each chapter contains information on legal requirements relating to the key stages in the life cycle of a regulated product, from discovery, through the clinical development process, registration, manufacturing and promotion, plus other issues of special interest, such as pricing and reimbursement, special liability regimes, competition and commercial transactions in the context of the medical products business. Each of the chapters has been prepared by a recognised expert in the relevant jurisdiction, and the resulting work product will assist industry lawyers, regulatory affairs staff and others who need to have an understanding of the issues in each major market.

There is also a chapter on international harmonisation, which plays an increasingly important role in the regulation of pharmaceuticals and medical devices. In particular, the guidelines adopted by the International Conference on Harmonisation have been incorporated into the national requirements for pharmaceuticals in the European Union, United States, Japan and most other developed countries, and are increasingly influential in developing countries.

About the Editor

Richard Kingham is a partner in the firm of Covington & Burling LLP, where he serves as co-head of the life sciences industry group and the industry, regulatory and legislative practice group. He previously served as the managing partner of the firm’s London office and as a member of the firm-wide management committee. Since joining the firm in 1973, he has concentrated on regulation of pharmaceuticals and related products. He has acted for most of the major pharmaceutical and biotechnology companies in the United States and Europe, as well as the principal trade associations of the pharmaceutical industry. He has served on committees of the World Health Organization, the Center for Global Development, the Institute of Medicine of the US National Academy of Sciences and the National Institutes of Health. He is currently an adjunct professor at the Georgetown University Law Center, and he has lectured at the University of Virginia School of Law and the graduate programme in pharmaceutical medicine at Cardiff University. He received his law degree in 1973 from the University of Virginia, where he served as articles editor of the law review and was elected to the Order of the Coif (the law school honour society).

Acknowledgements

The publisher acknowledges and thanks the following for their learned assistance throughout the preparation of this book:

Editor's Preface

  • Richard Kingham
  • Covington & Burling LLP

International Harmonisation

  • Richard Kingham
  • Covington & Burling LLP

Argentina

  • Emilio N Vogelius
  • Estudio Beccar Varela

Australia

  • Bernard O’Shea
  • Norton Rose Fulbright

Austria

  • Karina Hellbert
  • Fiebinger Polak Leon & Partner Rechtsanw älte GmbH

Belgium

  • Peter Bogaert and Charlotte Ryckman
  • Covington & Burling LLP

Brazil

  • Beatriz MA Camargo Kestener, Rubens Granja and Marco Aurélio Antas Torronteguy
  • Kestener, Granja & Vieira Advogados

Canada

  • Jill Daley, Randy Sutton and Kristin Wall
  • Norton Rose Fulbright Canada LLP

China

  • Shaoyu Chen and John Balzano
  • Covington & Burling LLP

Denmark

  • Mikkel Vittrup and Mette Hygum Clausen
  • Plesner Law Firm

Ecuador

  • Álvaro Sevilla, María de Lourdes Maldonado, Hipatia Donoso and José Antonio Fabara
  • Tobar ZVS

European Union

  • Grant Castle and Robin Blaney
  • Covington & Burling LLP

Finland

  • Hanna Paloheimo and Hilma-Karoliina Markkanen
  • Castrén & Snellman Attorneys Ltd

France

  • Sophie Pelé
  • Dechert LLP

Germany

  • Christian Dierks and Daniel Geiger
  • Dierks + Bohle

Greece

  • Gregory Triantafillopoulos
  • Bahas, Gramatidis & Partners

India

  • Pravin Anand and Archana Shanker
  • Anand and Anand

Israel

  • Dovev Apel
  • S. Horowitz & Co

Italy

  • Giovanni Galimberti, Massimiliano Mostardini, Mauro Turrini and Evelina Marchesoni
  • Studio Legale Bird & Bird

Japan

  • Kenji Utsumi and Kensuke Suzuki
  • Nagashima Ohno & Tsunematsu

Korea

  • Jung Min Jo
  • Bae, Kim & Lee LLC

Lithuania

  • Rūta Pumputienė and Ieva Balėnė
  • Ruta Pumputiene Law Firm

Mexico

  • José Alberto Campos-Vargas
  • Sánchez Devanny

New Zealand

  • Robert Andrew Bycroft
  • Tompkins Wake Lawyers

Norway

  • Are Stenvik, Beret Sundet, Andreas Bjørnebye, Eirik Basmo Ellingsen, Christoffer Mollestad and Ylva Kolsrud Lønvik
  • Advokatfirmaet BA-HR DA

Poland

  • Ewa Skrzydło-Tefelska and Jacek Myszko
  • Sołtysiński Kawecki & Szlęzak

Portugal

  • Paulo Pinheiro and Francisca Paulouro
  • Vieira de Almeida & Associados

Russia

  • Evgeny Alexandrov and Ilya Goryachev
  • Gorodissky & Partners Law Firm

Serbia

  • Bogdan Ivaniševićand Slobodan Trivić
  • BDK Advokati/Attorneys at Law

Singapore

  • Melanie Ho and Charmaine Neo
  • WongPartnership LLP

South Africa

  • Andrew Parsons, Allison Williams, Liesel Kok and Rosalind Lake
  • Norton Rose Fulbright South Africa Inc

Spain

  • Jordi Faus and Juan Suárez
  • Faus & Moliner

Sweden

  • Peter Forsberg and Axel Resvik
  • Hannes Snellman Attorneys Ltd

Switzerland

  • Markus Schott and Markus Wang
  • Bär & Karrer AG

Taiwan

  • Katherine YC Juang, Jill Niu and Daisy Wang
  • Lee and Li, Attorneys-at-Law

Turkey

  • Selma Ünlü
  • NSN Law Firm

United Kingdom

  • Grant Castle and Sarah Cowlishaw
  • Covington & Burling LLP

USA

  • Richard Kingham and Krista Hessler Carver
  • Covington & Burling LLP

Vietnam

  • Vo Ha Duyen, Kevin Hawkins and Pham Si Hai Quynh
  • VILAF

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