Regulatory Protection in the Pharmaceutical and Life Science Industries: Challen
$ 107.38
Description
Regulatory Protection in the Pharmaceutical and Life Science Industries: Challen. The book illustrates how regulatory exclusivities and rewards are granted, what protection they confer, and how they can be enforced. Recognising their practical importance, it further presents how regulatory protection is integrated into IP strategies and what challenges this may pose. Regulatory Protection in the Pharmaceutical and Life Science Industries by Żaneta Zemła-Pacud Estimated delivery 3-12 business days Format Hardcover Condition Brand New Description This book comprehensively elaborates on the EU framework for regulatory protection in life science industries. aneta Zema-Pacud discusses the rules governing regulatory exclusivities and rewards for both innovative life science products and the regulatory data underlying them. The analysis focuses primarily on pharmaceuticals, such as reference medicinal products, orphan drugs and paediatric medicines, but it also encompasses goods from the agrochemical and food sectors, such as plant protection products, novel food, genetically modified food and feed.The book illustrates how regulatory exclusivities and rewards are granted, what protection they confer, and how they can be enforced. Recognising their practical importance, it further presents how regulatory protection is integrated into IP strategies and what challenges this may pose. Against this background, the author presents and comments on coming changes to the system and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation. To complete the picture of regulatory protection in the EU, the book situates the system within the framework of other protective regimes, including the protection of regulatory data against disclosure. Finally, referring to European civil law tradition, the author carefully analyses the framework's normative legal bases and proposes categorising regulatory protection as a sui generis instrument of protection for Intellectual Property.This book is an insightful and stimulating contribution to the literature on intellectual property and pharmaceutical law. It is an essential read for scholars in those fields and policymakers involved in the legal reform of the pharmaceutical sector. Practising lawyers, judges, and national regulators will greatly benefit from timely insights into the field. Details ISBN 1035332272 ISBN-13 9781035332274 Title Regulatory Protection in the Pharmaceutical and Life Science Industries Author Żaneta Zemła-Pacud Format Hardcover Year 2025 Pages 270 Publisher Edward Elgar Publishing Ltd GEItemID:174442936; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items - you're bound to find what you want, at a price you'll love! Shipping & Delivery Times Shipping is FREE to any address in USA. Please view eBay estimated delivery times at the top of the listing. Deliveries are made by either USPS or Courier. We are unable to deliver faster than stated. International deliveries will take 1-6 weeks. NOTE: We are unable to offer combined shipping for multiple items purchased. This is because our items are shipped from different locations. Returns If you wish to return an item, please consult our Returns Policy as below: Please contact Customer Services and request "Return Authorisation" before you send your item back to us. Unauthorised returns will not be accepted. Returns must be postmarked within 4 business days of authorisation and must be in resellable condition. Returns are shipped at the customer's risk. We cannot take responsibility for items which are lost or damaged in transit. For purchases where a shipping charge was paid, there will be no refund of the original shipping charge. Additional Questions If you have any questions please feel free to Contact Us. Categories Baby Books Electronics Fashion Games Health & Beauty Home, Garden & Pets Movies Music Sports & Outdoors Toys
