This book provides an overview and practical guidance in life sciences law to readers in Switzerland and worldwide. Focusing on medicinal products and medical devices, it follows the value chain from the bench to the market. The main topics addressed include recent regulatory developments and cross-cutting issues relevant for any phase of a product life cycle, such as intellectual property rights, commercial agreements, dispute resolution, incorporation and fundraising, competition law and data protection.
Written for readers with diverse backgrounds such as in-house and external counsel, scientists, entrepreneurs, technology transfer professionals, engineers, investors and students, the book provides practical advice, case studies, references to further information, a glossary, and numerous graphs and tables to highlight key points.
Though focusing on Swiss law, the book also reflects the international scope of life sciences-related transactions by referencing European Union law and presenting selected topics relevant for operations in the USA and China.
Barbara Schroeder de Castro Lopes is in-house counsel in a large life sciences company. Previously, she worked for the Swiss federal government and judiciary and in a leading Swiss law firm. Judith Schallnau is in-house counsel in a large life sciences company. She worked at the World Intellectual Property Organization, at a leading research centre and as external counsel.
«The book on Life Sciences Law by Barbara Schroeder de Castro Lopes and Judith Schallnau perfectly explains this legal framework in a concise, but nonetheless comprehensive and very understandable way. [...] The authors provide the means for a first approach into the matter in a very structured way whilst giving access to the necessary information to dig deeper into it. [...]
From a practical point of view, the book contains a very useful glossary explaining in simple words each technical expression referred with an asterisk in the text. It also includes numerous tables that summarise chapters and key issues, allowing the reader to understand them at a glance. At the end of each chapter, references allow to search and obtain further information on each subject. This will certainly be of great use for practitioners. This book belongs to the library of any person interested in the matter, be it as a first read, or as a source of information for students or legal counsels and practitioners. For people with large experience and practice, this excellent book will serve as a perfect refresher in such a complicated issue.
As a conclusion, this book totally fulfils its goal: to provide an overview and practical guidance in life sciences law for readers in Switzerland and elsewhere, which are in particular interested in the way legal frameworks handle life science law in Switzerland and Europe, with some insights into China and the USA. A must-have.»
– Prof. Dr. Daniel Kraus, LL.M, Chair of Innovation Law, University of Neuchatel, Director [PI] 2, Attorney at Law (Vialex.ch), GRUR Int. 2019, pp. 623-624.
«[Das Buch] bietet einen erstklassigen Überblick über die vielseitigen Aspekte des ‹Life Sciences›-Rechts mit Fokus auf die Schweiz. [...] Dank den übersichtlichen und praxisnahen Abhandlungen dürfte es innert Kürze zu einem Standardwerk unter den Praktikern im ‹Life Sciences›-Recht avancieren. [...] Insgesamt verdient das in jeder Hinsicht fundiert erarbeitete Werk von Schroeder de Castro Lopes und Schallnau und den beteiligten Mitautoren vorbehaltlose Anerkennung. Inhaltlich sind die relevanten rechtlichen und regulatorischen Themen im Pharma- bzw. Medtech-Bereich praxisnah und verständlich beschrieben, und dank einer überzeugenden Gliederung und zahlreicher nützlicher Handlungsanleitungen und schematischer Darstellungen können spezifische Antworten und Inputs für die Praxis gezielt und schnell gefunden werden.»
– Cécile Matter, sic! 7/8/2019, S. 467ff.