Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Table of Contents
Chapter 1: Introduction to Regulatory Strategy
Chapter 2: The Regulatory Team
Chapter 3: Regulatory Intelligence Step 1: Information Collection—A Compilation of Website Addresses
Chapter 4: The Elements of Global Regulatory Strategy—the Basics
Chapter 5: Assembling and Utilizing Target Product Profiles
Chapter 6: Preclinical Safety Guidelines Supporting International Drug Registration
Chapter 7: CMC Regulatory Strategy
Chapter 8: Strategies for Clinical Development Planning
Chapter 9: Clinical Trial Application Planning
Chapter 10: Global Orphan Drug Regulations
Chapter 11: Pediatric Strategies
Chapter 12: So Your Drug has a Friend? Companion Diagnostic Codevelopment Strategies
Chapter 13: Interacting With Regulators
Chapter 14: Regulatory Pathways
Chapter 15: Global Regulatory Strategy
Chapter 16: Preparing for an FDA Advisory Committee: High Risk, High Reward
Chapter 17: Considerations for Healthcare Products’ Lifecycle Management
Chapter 18: Medical Writing Strategies: Aligning Regulatory Documents with Strategic Goals
William K. Sietsema, PhD and Monica M. Meacham, PhD, editors
About the Book
Available formats: print, e-book, and 3-year digital subscription
Understanding enhanced regulatory science and strategy and translating new discoveries into real-world products can make an enormous difference for individual and population health. However, doing so is fraught with challenges requiring coordinated work across disciplines, sectors and, increasingly, across nations.
The new edition of Global Pharmaceutical and Biologics Regulatory Strategy outlines a systematic approach, spanning everything from the earliest stages of research and development to postmarketing, taking into account the challenges and realities of a global strategy to meet the requirements of multiple regulatory systems.
Updated by a group of distinguished regulatory experts, this second edition provides the essential elements of an integrated regulatory approach, including the ABCs of regulatory strategy and the whys and wherefores of interacting with regulators. Other chapters cover more technical aspects of the product lifecycle and regulatory oversight, such as preclinical and clinical development, expedited pathways, orphan designation, pediatric products, and product formulation, manufacturing and control.
Who will benefit from this book?
This new edition is a must-have handbook for regulatory professionals at all levels. It includes updated information as well as new insights to help you reach your strategic goals in a more effective and cost-efficient manner.
Purchasing Options
This book can be purchased in the following formats:
- Subscription.* A three-year subscription including the digital e-book version as well as automatic updates whenever a new edition and/or chapters are released during the subscription period. Learn more about the subscription.
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
*All subscriptions listed above (excluding the All Access Library) are for three years. They grant you access to the products in the bundle. During this period, you can read the content online or download books as PDFs for offline use. You’ll also receive automatic updates to any new editions of the books and/or chapters included in your subscription. Learn more about subscriptions.
Published by RAPS © 2020. Paperback. 257 pages. ISBN (print): 978-1-947493-41-4. ISBN (digital): 978-1-947493-42-1.
