Alquest CEO to Deliver Opening Talk at 2009 Southeastern Medical Device Association Conference.Medical device regulation under the Obama administration and new Congress ATLANTA -- Linda Alexander, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Alquest, Inc. - the medical device industry's leading regulatory and clinical services firm - will deliver the opening presentation at the Feb. 10 Southeastern Medical Device Association Conference. Alexander will discuss potential changes in FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. medical device regulation under the Obama administration and new Congress. Her talk will cover: * current economic realities * commercialization planning, and development timelines and costs * the new Congress, including hot buttons of certain key Congressional members * emerging clinical data requirements * post-market approval requirements * FDA's agency mindset mind·set or mind-set n. 1. A fixed mental attitude or disposition that predetermines a person's responses to and interpretations of situations. 2. An inclination or a habit. for 2009 Before founding Alquest 16 years ago, Alexander was a regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: au·di·ol·o·gy n. , interventional vascular, dental, neurovascular, orthopedic, plastic surgery, general surgery, neurology, gastroenterology gastroenterology Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833. and urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. . SEMDA's annual conferences have become the Southeast's premier gathering for the medical device industry. The 2009 event will be held Tuesday, Feb., 10 at the Georgia Aquarium, 225 Baker Street, in Atlanta, from 8 a.m. to 5 p.m. For more information, visit http://www.semda.net/conference/ About Alquest Alquest is a U.S.-based regulatory and clinical services firm (Contract Research Organization - CRO) specialized in medical devices, in vitro diagnostics In vitro diagnostic (IVD) tests are medical tests conducted in a test tube, or more generally in a controlled environment outside a living organism. In vitro means in glass in Latin. and combination products. Alquest provides full-service regulatory, clinical and compliance services through its offices in Minneapolis, Minn., and Los Altos, Calif. Since 1993 Alquest has supported more than 400 medical device firms worldwide. For more information, visit www.alquest.com. About SEMDA Created in 2004 the Southeastern Medical Device Association (SEMDA) is a non-profit trade association that supports and promotes medical device companies in the Southeast. The association provides a unique resource and networking opportunity for medical device companies, inventors, physicians and investors interested in accelerating the growth of the medical device industry in the Southeast. For more information, visit www.semda.net. |
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