I don’t think a regulatory person should just pick up data and put them together into a submission and send it off to FDA without understanding the science.
Rockville, MD (PRWEB) March 30, 2012
The Regulatory Affairs Professionals Society (RAPS) has published the new book From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories, a collection of articles from Regulatory Focus and other publications written by pharmacist and seasoned regulatory expert Max Sherman.
The book covers a range of diverse and occasionally unusual subjects related to the practice of medicine, medical research, regulatory issues, biology, chemistry and other related disciplines. Some of Sherman’s articles address business and management issues associated with the regulatory profession, but most provide an in-depth look at subjects as varied as Alzheimer's and zebrafish—each offers unique insight and brings to light facts with which most readers are unfamiliar, even on seemingly common topics.
“I think regulatory people are mostly very curious,” said Sherman in an interview in Regulatory Focus. “I don’t think a regulatory person should just pick up data and put them together into a submission and send it off to FDA without understanding the science. I wrote about Zebrafish, for example, because I think people need to know the science behind using Zebrafish in a submission. You might have to explain that to someone in an FDA meeting. If you understand these things, I believe it gives you a stronger voice in front of FDA and others.”
From Alzheimer’s to Zebrafish: Eclectic Science and Regulatory Stories is available for purchase online from the RAPS Store for $34.95 (US) for RAPS members, or $39.95 for nonmembers. RAPS members get free shipping on all orders of more than $100.
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. Regulatory professionals play vital roles in making better healthcare products possible. They work throughout the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession by providing education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge-sharing, publications, networking, career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. RAPS is headquartered near Washington, DC, with offices in Brussels and Tokyo. RAPS.org