The emergence of Regulatory Science
October 16, 2010 12:00 AM
|
Regulatory science is the art and science of taking new medical and food products to market and keeping them on the market, under the constraints of a variety of laws and requirements. According to the recent FDA report devoted to this emerging field, regulatory science has the potential to inform a broad range of health-related advances, involving numerous diseases and conditions. Contrary to conventional wisdom, regulatory science does not take place only in laboratories.
Regulatory science includes a broad range of responsibilities and a firm understanding of both the drug- or food- development process and the continuum of research and regulations along that process. In particular, regulatory science includes regulatory affairs, regulatory writing, risk management, compliance, and regulatory law. Thus, for instance, every step in biomedical product development is regulated: research and development, preclinical studies, clinical studies, the manufacturing process, marketing, and post-marketing surveillance. So, it follows that regulatory scientists work at each one of those steps, evaluating product candidates and trials, mediating among interested parties, finding compromise and gaining consensus.
While some regulatory scientists are employed by scientific agencies around the industrialized world, such as FDA or EPA in the US, EFSA or EMA in Europe, most of them are employed by companies developing inter alia food, pharmaceutical and devices. Their job there is to make sure that the company abide by all regulations and guidelines for every product, in every country in which a product will be marketed, even before the regulatory agencies gets involved. No surprise that the job is becoming more and more demanding with the increased interconnected character of trade exchanges in fast moving consumer products.
.jpg) Regulatory scientists, notably those working in the private sector, are well compensated. A 2006 survey by the Regulatory Affairs Professionals Society looked at salaries and found the average salary for Ph.D. holders to be about $142,000. Those with bachelor's degrees earn about $95,000.
Last February, declaring that it's time to "accelerate and illuminate the pathway from microscope to market," U.S. Department of Health and Human Services Secretary Kathleen Sebelius announced a landmark collaboration between FDA and the National Institutes of Health in regulatory science. The agencies will award $6.75 million in research grants for projects that provide new methods, models, or technologies relevant to evaluating safety and efficacy during the development of medical products.
While in the past, people working in regulatory science typically learned the ins and outs of regulatory work on the job - but not necessarily at a regulatory agency, today there are dozens of regulatory science programs offered mainly at US Universities. For an overview of those programs you can visit the webpage of the Regulatory Affairs Professionals Society (RAPS).
For more information on regulatory science you can check the blog of my friend and colleague, Charles Woodhouse, a senior food lawyer with great expertise in criminal defense in USFDA, US Customs, Lacey Act, and USDA matters.
Where the EU emerging risk regulation system stands on regulatory science today?
|
Comments
©2012 all rights reserved
