Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Device

Description: Medical Product Regulatory Affairs by John J. Tobin, Gary Walsh Estimated delivery 3-12 business days Format Hardcover Condition Brand New Description Building on the success of its predecessor, this second edition of the hands-on guide to how pharmaceutical and medical devices are regulated within the major global markets has an even wider scope and now features case studies. The new EU-framework and US regulations are also fully integrated. Publisher Description Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeiaRegulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentationDrug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and deliveryNon-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalenceClinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic. Author Biography John J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company that employed several 100 people to develop and manufacture in vitro diagnostic reagents. Gary Walsh is chair of industrial biotechnology at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical and diagnostic industries as well as extensive teaching and research interests in the pharmaceutical and biotechnology arena. Details ISBN 3527333266 ISBN-13 9783527333264 Title Medical Product Regulatory Affairs Author John J. Tobin, Gary Walsh Format Hardcover Year 2023 Pages 336 Edition 2nd Publisher Wiley-VCH Verlag GmbH GE_Item_ID:158276739; 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

Price: 104.42 USD

Location: Fairfield, Ohio

End Time: 2024-12-01T04:04:05.000Z

Shipping Cost: 0 USD