Home > Books > Medical Product Regulatory Affairs
Medical Product Regulatory Affairs
View PDF

Medical Product Regulatory Affairs

Publication Year: 2008
Edition: 1st
Authors/Editor: Tobin, John J. and Walsh, Gary
Publisher: Wiley
ISBN: 978-3-527-31877-3
  • Description
  • Details

Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and 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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.

The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

  • Platform:
    Ovid
  • Publisher: Wiley
  • Product Type: Book
  • Author/Editor: Tobin, John J. and Walsh, Gary
  • ISBN: 978-3-527-31877-3
  • Specialty:
    Molecular Biology
  • Language: English
  • Edition: 1st
  • Pages: 297
  • Illustrations: 0
  • Year: 2008

Free Instant Access
This Month

JOTM
Social Policy & Practice A comprehensive bibliographic database, SSP helps professionals, practitioners, researchers, and students to understand, plan, and evaluate existing and future social policy.
JOTM
Visible Body Muscle Premium 3D interactive specialty module illustrates the basic movement of a variety of muscles throughout the human body as they interact with bone, nerves, and ligaments.
JOTM
Anesthesia & Analgesia Official journal of the International Anesthesia Research Society, provides the practice-oriented, clinical research to keep current and provide optimal care to patients.
JOTM
PAIN® Official publication of the International Association for the Study of Pain, publishes original research on the nature, mechanisms and treatment of pain.

Noteworthy

Doody's Featured Books
Harborview Illustrated Tips and Tricks in Fracture Surgery, 2nd Alumni Edition
Graduates of the Orthopaedic Trauma program at the University of Washington Harborview Medical Center provide tips and tricks gleaned from their years of professional practice.

Illustrated Tips and Tricks in Sports Medicine Surgery
Succinct, precise information from a wide range of experts and prestigious institutions on tackling technical problems in sports medicine surgery.