Pharmaceutical Test Data Exclusivity is popular PDF and ePub book, written by John C. Todaro in 2022-08-12, it is a fantastic choice for those who relish reading online the Law genre. Let's immerse ourselves in this engaging Law book by exploring the summary and details provided below. Remember, Pharmaceutical Test Data Exclusivity can be Read Online from any device for your convenience.
Pharmaceutical Test Data Exclusivity Book PDF Summary
Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice – local experts provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following: infectious disease products; paediatrics products; chemical and biological products; agricultural products; animal health products; orphan drugs; and new chemical entities. This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world’s leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices.
Detail Book of Pharmaceutical Test Data Exclusivity PDF
- Author : John C. Todaro
- Release : 12 August 2022
- Publisher : Kluwer Law International B.V.
- ISBN : 9789403501369
- Genre : Law
- Total Page : 250 pages
- Language : English
- PDF File Size : 14,5 Mb
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