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FDAnews Guide to International Pharma Regulation: 2013 Edition

Published: February 2013 |  Pages: 362 |  Price:  $387  | ISBN:  978-1-60428-087-6  | Table of Contents
In drug manufacturing, success means staying abreast of regulatory changes from Australia to Zimbabwe ... and beyond.

Impossible? Not at all. Here’s how:

Announcing the 2013 edition of the ...

FDAnews Guide to International Pharma Regulation

It’s the one-stop authority for quick, accurate answers to all your questions on:

  • Clinical trials regulations
  • Emerging changes in inspection practices
  • Changes to quality manufacturing requirements
  • Developing biosimilars approvals pathways
  • New labeling and marketing regulations
  • Changing product registration requirements
  • Pricing and reimbursement debates
  • Anti-counterfeiting measures
  • And dozens more key topics in drug regulation worldwide.

International compliance is no longer simply a matter of playing by the same old rules. There’s been a dramatic increase in foreign inspections. Many countries are collaborating via joint inspections and confidentiality agreements that permit sharing of inspection results. And in many countries, drug safety concerns are prompting new requirements. You learn the new rules of the game, or cede the playing field to competitors.

That’s where the FDAnews Guide to International Pharma Regulation: 2013 Edition comes in. Our editors monitor and report on regulatory developments affecting drug production in more than 45 nations around the world. They’ve compiled more than 150 reports highlighting changes from the past year that could supercharge your international sales ... or stop them in their tracks.

You’ll turn to this total regulatory reference time and again in the months ahead. It will become your one-stop source for:

  • Coverage of the EU, Asia, Latin America, the Middle East, North America and Australia/Pacific
  • Essential international regulatory changes from all of 2012
  • Comprehensive summaries and explanations of the changes
  • Key regulations – full-text printouts
  • And much more!

To compete internationally, you must comply internationally. It’s a lesson your competitors have learned. Don’t get left behind. Place your advance order now.

Buy Now

FDAnews Guide to International Pharma Regulation – 2013 Edition is available for advance ordering at a special low price of $387. After the February 2013 publication date, the price may change. That’s why it’s a good idea to order now.

FDAnews Guide to International Pharma Regulation – 2013 Edition will be published in print and CD format.

Satisfaction Guaranteed

Your purchase is 100% guaranteed. If for any reason you decide the report is not for you, simply return the undamaged hard copy within 30 days of purchase and you'll receive a full refund (less shipping/handling). For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase to receive a refund.

Interested in purchasing more than one print copy?
Significant volume discounts are available for ordering three or more copies of the same book. You must order them at the same time and provide a single payment to take advantage of the discount. Order below by clicking submit and then change your quantity in the shopping cart. The discount will be calculated automatically.

3-4 copies – 10%
5-6 copies – 15%
7-9 copies – 20%
10+ copies – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally with any questions.

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Print Version

CD Version

ISBN: 978-1-60428-087-6 ISBN: 978-1-60428-088-3