Regulatory Pros Spend More Time on Strategy
RAPS survey finds most regulatory professional have multiregional or worldwide responsibilities and are spending more time on strategic activities.
The Regulatory Affairs Professionals Society (RAPS) released its biennial survey, the 2016 Scope of Practice & Compensation Report for the Regulatory Profession, featuring results from 3,358 regulatory professionals in 56 countries.
Among the most significant findings, regulatory professionals are spending more of their time on strategic activities and less time on tasks related to research and development, clinical testing, product registration and other preapproval activities. Overall, compensation has increased, but more for those at mid-level positions, than those at senior levels.
Most regulatory professionals have multiregional or worldwide responsibilities, and work with multiple types of healthcare products. More than 88% of regulatory professionals began working in another field before transitioning into regulatory, and most have significant prior professional experience, usually in a related field., and more than 20% have a doctorate.
Read the full release.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
