Life sciences law / Barbara Schroeder de Castro Lopes, lic. iur., LL. M. (Bruges), Attorney at Law; Judith Schallnau, LL. M. (Bruges), Attorney at Law.
Life sciences law / Barbara Schroeder de Castro Lopes, lic. iur., LL. M. (Bruges), Attorney at Law; Judith Schallnau, LL. M. (Bruges), Attorney at Law.
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