This Women’s History Month, GLOBAL employees will highlight how women revolutionized science and medicine. In this blog post, Tracy Janus, Sr. VP of Regulatory Affairs & CMC, shares how century-old advice from Florence Nightingale helped us through the largest public health threat our generation has had to face.
Florence Nightingale (1820 – 1910) changed the face of nursing and healthcare globally and is regarded as the mother of modern nursing. She contributed significantly to the establishment of nursing as a respected profession for women. Her most famous book is titled "Notes on Nursing: What It Is, and What It Is Not." First published in 1859, the book aimed to improve the standards of nursing care and served as a basic instruction manual for student nurses.
However, her legacy extended beyond nursing into healthcare management, epidemiology, and public health. Nightingale’s work and philosophies have not only stood the test of time, but her teachings were instrumental in guiding policymakers and healthcare professionals during the COVID-19 pandemic. Here are some examples:
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In April of this year, FAERS finalized the new process for submitting required safety reports through the Electronic Submissions Gateway (ESG). Read more for how this affects regulatory publishing.
A few months ago, we announced our partnership with Vistatec Life Sciences. This partnership delivers integrated, accurate, translated regulatory writing combined with expert localization expertise that helps organizations accelerate global submissions with clarity, confidence, and compliance.
The European Commission has proposed a series of updates to the EU Medical Device Regulation (MDR) aimed at improving efficiency, reducing burden, and addressing long-standing bottlenecks—particularly around Notified Body capacity, classification clarity, and clinical requirements.
