Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

Description: Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional by Raymond A. Huml Estimated delivery 3-12 business days Format Paperback Condition Brand New Description While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions. Publisher Description This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a products lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions. Author Biography Raymond A. Huml, MS, DVM, RAC is Executive Director of Global Due Diligence in Quintiles Capital Solutions ("Capital") for Quintiles Transnational Corp. Dr. Huml has over 20 years of experience in the biopharmaceutical industry. In his current position, Dr. Huml identifies risks associated with Quintiles global (US, EU and Japan) product-based investments, working with specialists on all components of the due diligence process, including research and development, commercial, intellectual property, and conflict of interest. He previously worked in Biostatistics, Medical Writing, and Regulatory Affairs Departments in Quintiles Clinical Development Services group. Dr. Huml has authored and co-authored numerous scientific publications, and is a strong supporter of the Regulatory Affairs Professionals Society (RAPS). He holds an MS in Biology from East Stroudsburg University and his DVM from North Carolina State Universitys College of Veterinary Medicine, and has earned the RAC (US) Certification. Details ISBN 1461436818 ISBN-13 9781461436812 Title Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional Author Raymond A. Huml Format Paperback Year 2012 Pages 82 Edition 2012th Publisher Springer-Verlag New York Inc. GE_Item_ID:137656151; 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: 77.47 USD

Location: Fairfield, Ohio

End Time: 2024-12-27T03:18:42.000Z

Shipping Cost: 0 USD