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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Twice-Yearly Lenacapavir Injections Significantly Reduce HIV Risk, PURPOSE 2 Trial Shows
November 13th 2024Full Phase III PURPOSE 2 trial results suggest that twice-yearly lenacapavir could revolutionize HIV prevention by offering a convenient and effective long-acting option for individuals at risk of infection.