Pharmaceutical Regulatory Process (Hardbound)

By 

Ira R Berry

  (Editor),

Robert P Martin

  (Editor)
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Pharmaceutical Regulatory Process Book Description

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.

New chapters cover:

  • the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
  • pharmacovigilance programs designed to prevent widespread safety issues
  • legal issues surrounding the sourcing of foreign APIs
  • the issues of counterfeit drugs
  • updates on quality standards

Book Details


Title: Pharmaceutical Regulatory Process
Publisher: Informa Healthcare
Author: Ira R Berry, Robert P Martin
Edition: Hardbound
Edition Number: 2
Language: English
ISBN:

1420070428

EAN:

9781420070422

No. of Pages: 469
Publish Date: 2008-12-31
Binding: Hardbound
Deliverable Countries: This product ships to India, Sri Lanka.

Similar Items by Category

Pharmacology  >  Medical
Administrative Law & Regulatory Practice  >  Law

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Inferno: The New Robert Langdon Thriller
The book Pharmaceutical Regulatory Process by Ira R Berry, Robert P Martin (author) is published or distributed by Informa Healthcare [1420070428, 9781420070422]. This particular edition was published on or around 2008-12-31 date. Pharmaceutical Regulatory Process has Hardbound binding and this format has 469 number of pages of content for use. The printed edition number of this book is 2. This book by Ira R Berry, Robert P Martin is written in English language.
* The book summary and image may be of a different edition or binding of the same title.
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* These books are NOT available for reading online or for free download in PDF or ebook format.
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