Dr. Hafez Selim, MD, PhD, is a physician-scientist working in pharmaceutical drug safety. Before moving to pharmaceuticals he spent nearly a decade as a medical advisor and safety physician in the spine division of a global medical device company, with safety leadership for clinical trials and oversight of a broad surgical portfolio. His regulatory experience spans the FDA, EMA, MHRA and PMDA, and covers development safety update reports, periodic benefit-risk evaluation reports, risk management plans, clinical evaluation reports and premarket submissions. He holds an MD from Ain Shams University, a PhD in anatomy and cell biology from Temple University, and a graduate diploma in applied biostatistics from the University of Minnesota, with postdoctoral training at Harvard Medical School and Massachusetts General Hospital. He has published 49 journal articles, holds four patents in biomaterials, and writes under the Selim Medical Press imprint.