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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
