Regulatory Intelligence Reimagined (subscription)

Linda Bowen, MS, RAC, FRAPS, editor

Contributing Authors

About the Book

Learn to drive real impact through regulatory intelligence at your organization.

Regulatory Intelligence Reimagined brings together today’s foremost experts to redefine how organizations approach RI. This 28-chapter comprehensive guide is designed to help both new and experienced professionals build, deploy, maintain, and evolve regulatory intelligence functions that drive real strategic impact.

A new approach to regulatory intelligence fully reimagined for today’s regulatory intelligence landscape:

• AI woven throughout turns data into actionable insights
• RI leaders share real-world lessons from their experiences
• Practical guidance to build, sustain, and grow high-performing RI teams
• Available in searchable e-book format, built for today’s regulatory professional

The book is organized into five sections – The Basics, Deliverables, Supporting Health Authority Interactions, The Policy Side, and The Intersection of Artificial Intelligence and Regulatory Intelligence – to create a clear and intuitive progression of ideas. The structure reflects not only how regulatory intelligence functions in practice, but also how it continues to expand in scope and sophistication.

To bring this framework to life, the book draws on the expertise of a truly diverse group of contributors – professionals actively practicing RI and policy across biopharma, medical devices, contract research organizations, and regulatory intelligence service organizations. Our authors represent companies both small and large, and they bring perspectives shaped by work in the US, UK, and across Europe. Their collective experience forms the backbone of this book.

Meet the Lead Editor

Linda Bowen, MS, RAC, FRAPS, is a distinguished regulatory affairs leader with more than three decades of experience shaping global regulatory strategy, intelligence, and policy. She has held senior roles at Pfizer (Seagen), Sanofi, Bayer, and GSK (Block Drug), where she built and led high performing teams and engaged extensively with health authorities, trade associations, industry consortia, and professional organizations worldwide. Linda has been an Adjunct Professor in Temple University’s RAQA graduate program since 1998. She holds Regulatory Affairs Certifications (RAC) for the US, Canada, and Europe and is a RAPS Fellow.

Her contributions have been recognized through multiple honors, including the RAPS 2020 Founder’s Award, the Drug Information Association’s 2012 Excellence in Volunteer Leadership Award, the 2019 Americas Inspire Award, and the 2022 Global Inspire Award for Community Engagement. She served on the RAPS Board of Directors and has served on the leadership team of the NJ/NY RAPS Chapter since its founding in 2003. She chaired RAPS Convergence in 2018 and 2019, serves on the 2024–2026 RAPS Regulatory Intelligence Conference Committee, and hosts the RAPS Regulatory Intelligence Collaborative Community.

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.
• 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)
• Regulatory Excellence Bundle: Pharmaceutical and Biologics (subscription).* Includes the digital e-book subscription to:
  • Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective
  • Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
  • Regulatory Intelligence Reimagined
• Regulatory Excellence Bundle: Medical Devices (subscription).* Includes the digital e-book subscription to:
  • Fundamentals of Medical Device Regulations: A Global Perspective
  • Global Medical Device Regulatory Strategy, Second Edition
  • Regulatory Intelligence Reimagined
• RAC exam test prep bundles

*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.