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Publisher:
CenterWatch

ISBN-13:
978-1-930624-62-7

Publication date:

Page count:
323

Preview sample pages:
Table of Contents

Introduction

Chapter 2:
Global regulatory affairs—role in the biopharmaceutical industry

Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration

Author:
Senior Vice President, Head, Global Regulatory Affairs, PPD,Inc.
Read more about the author.

Format(s):

Price: $195.00 

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Copyright notification: no part of this book may be reproduced in any manner without written permission from the publisher. Please refer to the copyright statement in the book.

Advance Praise:

"This informative, organized and well written text could be the new primer for the global regulatory environment. It should be on the bookshelf of every product development company."

—Laurie Halloran
CEO, Halloran Consulting Group

"Global Regulatory Systems is the first book to outline concisely the criteria regulatory agencies have established for drug approvals on a global basis. Professionals in pharma, biotech, CROs and academia will benefit from this book by learning how to ‘work’ with various global regulatory agencies to understand their timelines, guidelines and specific regulatory requirements in place for new drug development. Global Regulatory Systems is a book from which companies will learn upfront what agencies require in order to give them insight to develop drugs based on specific agency’s regulatory guidelines."

—Robert R. Ruffolo, Jr., Ph.D., D.Sc., D.Eng.
Retired President, Research & Development
Wyeth Pharmaceuticals

"Dr. Henrietta Ukwu provides an insightful perspective and breadth of experience on the worldwide regulatory systems that are critical to the success of clinical trials management. Global Regulatory Systems is an expansive and unparalleled manual for regulatory professionals that describes and helps navigate the complex and ever-changing global regulatory processes."

—Emilio A. Emini, Ph.D.
Chief Scientific Officer, Vaccine Research
Pfizer

"Regulatory professionals are routinely asked a variant of the "can we do this?" question. The task of answering this is nearly impossible without an understanding of global regulatory guidance and practices. Therefore, it is essential that every regulatory professional is armed with a framework for reference. Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration provides a broad, yet concise and detailed, summary of the major regulatory topics that invariably shape drug development programs, both operationally and strategically."

—Gregory Dombal
Managing Director, Halloran Consulting Group

"The Global Regulatory Systems book explores the complex global regulatory environment in the clinical trials industry in a systematic and structured manner. The graphs and tables compare and contrast the regulatory requirements of this dynamic landscape. The book is a compilation of the author’s passion for the subject, working knowledge, extensive experience and expertise for professionals and students to gain a better appreciation of the similarities and differences in regulations between various countries."

—Kinnari Narielwala
Temple University, MS QARA Program Student

Read a review by Norm Goldfarb, Managing Director of First Clinical Research.

CenterWatch introduces the most concise, yet comprehensive resource available on the major global regulatory systems—including the most relevant and pertinent regulatory facts and guidelines—consolidated into one, must-have and easy-to-read resource. This strategic roadmap takes the reader through a dynamic and complex landscape while providing a fundamental understanding and application of global regulatory principles to ensure successful product development and registration.

Topics include:

  • A breakdown of the major global regulatory systems and processes
  • A framework for approaching each system
  • Comparisons and contrasts of various regulatory agencies
  • A thorough analysis of regulatory roles and processes
  • Effective strategies for immediate development and implementation
  • Suggested exercises that challenge the reader
  • Nearly 200 charts and graphs

Featured countries/regions:

  • U.S.
  • Canada
  • Europe
  • Japan
  • Australia
  • Asia
  • Emerging markets including: Latin America, Central and Eastern Europe, Middle East and Africa

Recommended for:

  • New and current regulatory professionals from pharma, biotech, CROs
  • Product development and project managers
  • Undergraduate and graduate students
  • Professors of Regulatory Affairs
  • Academic researchers and investigators
  • Financial analysts