Posts tagged Advance

Rockville, MD (Vocus) 7 October 2010

Regulatory Affairs Professionals Society (RAPS) today announced its support for a new plan from the U.S. Food and Drug Administration (FDA) to promote the science of regulation. FDA issued its Regulatory Science Initiative this week and put the agencia? S right plan in a white paper against the regulation of public health sciences. Commissioner Margot Hamburg has discussed the plan and stressed the importance of investment in science regulatory during a speech yesterday at the National Press Club in Washington, DC.

RAPS Executive Director Sherry Keramidas

, PhD, CAE, said the plan. â? This is a critical moment in the history of medicine and medical technology. Scientific innovations could be a pioneer every day that a profound impact on the lives of patients need new therapies. But the translation of scientific advances on the bench patientsa? Bed is not an easy process. to ensure drugs and medical devices to be safe and effective, to the best scientific knowledge and processes. Regulatory science is to translate the most important link in the process in the laboratory discoveries into practical treatments in hospitals, doctorsâ? Offices and people? Homes across the country and around the world. RAPS applauded FDAâ? S commitment to science and regulatory support his plan to maximize their potential to public> support health.â ????

FDA White Paper sets out the science of the scheme? the science of the development of new tools and approaches to assess the safety, efficacy, quality and performance of the products selected by the FDA regulated? The concepts in the document clearly designed with the knowledge and scope of practice of regulatory professionals, RAPS as indicated in the 2010 scope of practice and remuneration.

â? While science can from the scheme broadly understood by the public, it is absolutely necessary to the development and availability of health care treatments and advanced in every part of the life cycle of products considered to be health, â? Keramidas said. â? The plan outlines FDA has the potential to be a real game-changer for public health and RAPS is committed to the opportunity to assist with officials of the Agency have FDAâ? Efforts in this area.if p ????

FDAâ? The initiative will be a four-part framework, the establishment of new centers of excellence in FDA Regulatory Science, supports the development of the Agencia covers? s in-house expertise and collaboration with external stakeholders.

to Hamburg

Commissioner first noted the importance of promoting science regulators since last year when she addressed the participants of the Conference and Exhibition 2009 RAPS Annual Report

Philadelphia.
about RAPS

The Regulatory Affairs Professionals Society (RAPS) is an international organization of regulatory professionals in the rapidly growing sectors of the medical devices, pharmaceuticals and biotechnology. Professionals play a regulatory role in the production of health care possible. They work throughout the life cycle of health products that these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession, in that it is education and training, Regulatory Affairs Certification (RAC), professional standards, research, knowledge sharing, publications, networks, opportunities for developing career and other valuable resources and set itself the target’s members continually develop the knowledge and skills they need to Excel. RAPS is located near Washington, DC, with offices in Brussels and Tokyo. RAPS.org

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