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000048222 008__ 190221s2019    gw|||||| |||||00||0 eng|d
000048222 020__ $$a9783038910251
000048222 020__ $$a9783848754045
000048222 035__ $$a(OCoLC)1393694726
000048222 040__ $$aSzGeWIPO$$beng
000048222 0410_ $$aeng
000048222 043__ $$ae-sz---
000048222 050_4 $$aKKW3098
000048222 08204 $$a344.49404233$$223
000048222 084__ $$aPJ 3260
000048222 084__ $$aG 25 CAS.L
000048222 1001_ $$aSchroeder de Castro Lopes, Barbara,$$eauthor.
000048222 24510 $$aLife sciences law /$$cBarbara Schroeder de Castro Lopes, lic. iur., LL. M. (Bruges), Attorney at Law;  Judith Schallnau, LL. M. (Bruges), Attorney at Law.
000048222 264_1 $$aZürich :$$bDike Verlag ;$$aBaden-Baden :$$bNomos Verlag,$$c2019.
000048222 300__ $$axlvi, 323 pages :$$billustrations ;$$c18 cm.
000048222 336__ $$atext$$btxt$$2rdacontent
000048222 337__ $$aunmediated$$bn$$2rdamedia
000048222 338__ $$avolume$$bnc$$2rdacarrier
000048222 504__ $$aIncludes bibliographical references.
000048222 5050_ $$aSummary of contents -- Preface -- Foreword -- Summary of contents -- Table of contents -- List of abbreviations -- Bibliography -- Chapter 1: Introduction -- 1. What is life sciences law? -- 2. Structure of the book -- 3. Key legal issues in life sciences at a glance -- Chapter 2: Research and innovation -- 4. Switzerland as a research location -- 5. Discovery and prototypes -- 6. Technology transfer -- 7. Research with microorganisms -- 8. Human research -- Chapter 3: Market access -- 9. Overview of the legislative framework -- 10. Marketing authorisation for medicinal products -- 11. Conformity assessment for medical devices -- 12. Pricing and reimbursement -- Chapter 4: Market-related activities -- 13. Manufacturing -- 14. Distribution -- 15. Market surveillance and vigilance -- 16. International trade: import and export -- 17. Product liability -- Chapter 5: Cross-cutting issues in life sciences law -- 18. Intellectual property -- 19. Commercial contracts -- 20. Dispute resolution -- 21. Incorporation and fundraising -- 22. Competition law -- 23. Data protection and data transparency -- Chapter 6: Selected legal issues in life sciences in the USA and China -- 24. Protecting pharmaceuticals in the United States -- 25. Regulatory framework of drug entry to China -- Glossary
000048222 520__ $$aThis book provides an overview and practical guidance in life sciences law to readers in Switzerland and worldwide such as in-house and external counsels, scientists, entrepreneurs, technology transfer professionals, engineers, national and foreign investors and students. Focusing on medicinal products and medical devices, this book follows the value chain from the bench to the market and includes numerous graphs and tables to summarize and illustrate key points. It provides readers from different backgrounds with practical advice and a glossary, and includes references to further information. An important part addresses cross-cutting issues relevant for any phase of a product life cycle, such as intellectual property rights, commercial agreements, dispute resolution, competition law, data protection, and financing. Although the book focuses on Swiss law, it takes into account the international scope of life sciences-related transactions by referencing European Union law and presenting selected topics relevant for life sciences stakeholders operating in the USA and China. Barbara Schroeder de Castro Lopes is in-house counsel in a large pharmaceutical corporation. Previously she worked for the Swiss government, at a Swiss federal court and in a leading Swiss law firm. Judith Schallnau is also in-house counsel in a large pharmaceutical corporation. She worked at the World Intellectual Property Organization, at a large research centre and as outside counsel.
000048222 650_0 $$aMedical laws and legislation$$zSwitzerland.
000048222 650_4 $$aLife sciences
000048222 650_0 $$aIntellectual property.
000048222 650_0 $$aPatents.
000048222 650_0 $$aLife sciences$$xLaw and legislation$$zSwitzerland.
000048222 653_4 $$aLife Sciences Law
000048222 7001_ $$aSchallnau, Judith,$$eauthor.
000048222 903__ $$aSwiss law in a nutshell series
000048222 904__ $$aBook
000048222 980__ $$aBIB