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Life sciences law / Barbara Schroeder de Castro Lopes, lic. iur., LL. M. (Bruges), Attorney at Law; Judith Schallnau, LL. M. (Bruges), Attorney at Law.
2019
PJ 3260
Available at WIPO Library
Items
Details
Title
Life sciences law / Barbara Schroeder de Castro Lopes, lic. iur., LL. M. (Bruges), Attorney at Law; Judith Schallnau, LL. M. (Bruges), Attorney at Law.
Item Type
Book
Description
xlvi, 323 pages : illustrations ; 18 cm.
ISBN
9783038910251
9783848754045
9783848754045
Alternate Call Number
PJ 3260
G 25 CAS.L
G 25 CAS.L
Summary
This 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.
Bibliography, etc. Note
Includes bibliographical references.
Formatted Contents Note
Summary 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
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
Published
Zürich : Dike Verlag ; Baden-Baden : Nomos Verlag, 2019.
Language
English
Record Appears in
all