Regulatory Intelligence 101 serves as an essential guide to the basics of conducting regulatory intelligence.
Regulatory intelligence (RI), the act of monitoring and analyzing available regulatory information, has become a crucial skill for regulatory professionals working in the pharmaceutical, medical device and biotechnology sectors. Regulatory Intelligence 101, new from the Regulatory Affairs Professionals Society (RAPS) serves as an essential guide to the basics of conducting regulatory intelligence.
Regulatory Intelligence 101 examines available regulatory intelligence tools, both free and those requiring a subscription, and gives tips on how to gatherinformation. Chapters cover everything from the basic regulatory intelligence toolbox to setting up a regulatory intelligence department within a company.
“This book is the culmination of my 14-year love affair with RI, a field that has allowed my affinity for regulatory and love of the profession to shine through,” writes author Meredith Brown-Tuttle, RAC, in the book’s introduction. “It reflects the contributions to the growth and development of RI through the years, and I am proud to have been part of the process.”
According to RAPS’ 2014 Scope of Practice & Compensation Report for the Regulatory Profession, regulatory intelligence currently represents an average of about 6% of regulatory professionals’ job responsibilities.
Regulatory Intelligence 101 is available from the RAPS Store for $44.95 (US) for RAPS members or $54.95 for nonmembers.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.