BURLINGTON, Mass., Aug. 19, 2013 /PRNewswire/ -- ParagonRx, an inVentiv Health company offering product safety risk management and healthcare systems consulting to pharmaceutical and medical device companies, announced today the appointment of Stephen W. Sun, MD, MPH, as Chief Medical Officer advising clients on regulatory and safety issues.
Dr. Sun, formerly with the U.S. Food and Drug Administration (FDA), will be reporting directly to ParagonRx President Jeffrey Fetterman.
His appointment comes at a time of dramatic regulatory change in both the United States and globally. Regulators are under pressure to speed review of new medical products while simultaneously improving safety. As a consequence, drug developers and device makers planning for a successful review must be proactive in assuring optimal and safe use of products before the products come up for review.
"The focus today is on enhanced pharmacovigilance, putting preventions in place before any regulatory body requires it," Fetterman said. "Dr. Sun's FDA experience will enrich the guidance we offer clients to assure that active risk management is at the core of developing all new products and services."
ParagonRx clients will have access to a savvy regulatory strategist in Dr. Sun, who understands the escalating scientific rigor regulators expect to see in filings. His public health experience also will benefit clients seeking counsel on the appropriate use of medications and devices designed to improve the well-being of large populations.
Dr. Sun earned his Bachelors of Science in Chemistry, Food, and Nutrition from Rutgers University, his medical degree from UMDNJ-New Jersey Medical School, and his Masters in Public Health from the Johns Hopkins Bloomberg School of Public Health.
While training in general surgery at Beth Israe
|SOURCE inVentiv Health, Inc.|
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