Global Medical Device Regulatory Strategy (subscription)

Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.

Section 1: General Considerations

Chapter 1: Good Documentation Practices
Chapter 2: General Considerations for Quality Regulatory Writing
Chapter 3: Developing Standard Operating Procedures and Planning and Strategy Documents
Chapter 4: Regulatory Authority Review and Approval Processes
Chapter 5: Responses to Questions or Requests for Information
Chapter 6: Interdisciplinary Document, Dossier Maintenance
Chapter 7: Accelerated Filings
Chapter 8: From Pens to Prompts: How AI is Redefining the Future of Medical Writing

Section 2: Clinical Trial Documents

Chapter 9: The Clinical Trial Information System (CTIS): The New Workspace for all Clinical Trial Activities in Europe (EU/EEA)
Chapter 10: Clinical Trial Protocols
Chapter 11: Informed Consent Form Preparation: The Whys, Whats, Whos, Whens, and Hows
Chapter 12: Statistical Analyses and Statistical Analysis Planning
Chapter 13: Clinical Study Reports
Chapter 14: Lay Summaries of Clinical Study Results
Chapter 15: Publications

Section 3: Integrated Documents

Chapter 16: Investigator’s Brochure
Chapter 17: Labeling
Chapter 18: Integrated Clinical Documentation
Chapter 19: Nonclinical Documentation
Chapter 20: Integrated Chemistry, Manufacturing, and Controls Documentation
Chapter 21: Value Dossiers and Health Technology Assessments
Chapter 22: Paediatric Investigational Plan
Chapter 23: Background Packages
Chapter 24: Literature Reviews
Chapter 25: From Concept to Care: Global Regulations for Medical Devices

Section 4: Sector-Specific Documentation

Chapter 26: Vaccines and Biologics
Chapter 27: Biosimilars: Special Considerations
Chapter 28: Combination Product Design and Development
Chapter 29: Rare Diseases: Special Considerations for Orphan Designations and Humanitarian Device Exemption

Peter A. Takes, PhD, RAC, FRAPS, and Susumu Nozawa, RAC, FRAPS, editors

Contributing Authors

About the Book

Available formats: print, e-book, and 3-year digital subscription

The second edition of Global Medical Device Regulatory Strategy includes timely updates on all chapters, current information on cybersecurity and software, new international regulations and a new chapter on driving successful commercial product launches. This book provides a how-to guide to developing a comprehensive global regulatory strategy for all types of medical devices, including discussions on the development and implementation of global regulatory strategies for medical devices, labeling, clinical, risk management, marketing and postmarketing. The use of standards and regulatory resources for strategy development is discussed as well as need for developing a comprehensive global regulatory process. Other topics include regulation of therapies, devices, combination products and in vitro diagnostic medical devices.

Who will benefit from this book?

This book is intended for both the experienced regulatory professional and those entering the profession and designing their own pathway to success in this vastly enriching field. It can be used as a contemporary and integral bookshelf reference in Regulatory Affairs departments of all sizes, as well as a routine textbook in expanding academic curricula in regulatory affairs and quality systems.

Purchasing Options

This book can be purchased in the following formats:

Subscription.* A three-year subscription including the digital version listed above 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.

Return to listing