YOQNEAM, Israel, Oct. 19 /PRNewswire-FirstCall/ -- Given Imaging Ltd. (NASDAQ:GIVN) today announced that Shoshana (Shosh) Friedman, Corporate Vice president, Regulatory and Medical Affairs has been awarded the Richard E. Greco Award by the Regulatory Affairs Professionals Society (RAPS).
The Richard E. Greco Award is the highest honor bestowed by RAPS and recognizes outstanding leaders who have made significant contributions to the regulatory affairs profession and to the RAPS organization.
"We congratulate Shosh on receiving this prestigious award and are proud that her peers have honored her achievements. Shosh has been instrumental in helping Given Imaging to build collaborative and productive relationships with regulatory agencies worldwide and we know this award is well deserved," said Gavriel D. Meron, president and chief executive officer of Given Imaging.
Ms. Friedman joined Given Imaging in 2002. She has been a member of the company's Advisory Board since June 1997 and, as a company consultant, led the activities for getting marketing authorization worldwide (U.S. Food and Drug Administration clearance, CE-mark, Canadian License, Australian Listing). Prior to joining Given Imaging, Ms. Friedman founded and served as Managing Director of Push-med Ltd., a regulatory consulting firm that provides regulatory services to medical device and biotechnology companies. Before that, Ms. Friedman served as Regulatory, Clinical and Quality Assurance Director at InStent Ltd., an Israeli medical device company that was acquired by Medtronic Inc. in 1996. Shosh is considered a pioneer in the Israeli regulatory affairs community. In her many years of activity she has succeeded to educate the Israeli medical companies in the implementation of regulatory requirements as a substantial and critical part of their activity for a successful entrance into the international markets. Ms. Friedman holds a B.Sc. in mathematics and physics from Haifa University, an MBA from Hebrew University, a QA Lead Assessor certification from Bywater, and a Regulatory Affairs Certification (RAC) from RAPS.
About RAPS(R) The Regulatory Affairs Professionals Society (RAPS) is the foremost worldwide member organization creating and upholding standards of ethics, credentialing and education for the regulatory affairs (RA) profession within the health product sector. Founded in 1976, RAPS represents nearly 10,000 individuals worldwide, working in government, corporations, academia, research and nonprofit organizations.
As the global source for Regulatory Affairs Certification (RAC), the RA Code of Ethics, proprietary research and educational products, international conferences and the leading professional magazine, Regulatory Affairs Focus, RAPS establishes industry standards for professionalism, knowledge and achievement. Through expert education and resources, RAPS provides regulatory affairs professionals with the tools necessary to create strategic value for their organizations. The RA profession is vital to the development, approval and provision of health products, including pharmaceuticals, biologics and biotechnology, medical devices, cosmetics, veterinary products and nutritional supplements.
RAPS is a nonprofit educational/scientific organization with headquarters in Rockville, MD, and members in 45 countries in Asia, Europe, Latin America, the Middle East, North American and the Pacific Rim. RAPS is located at 11300 Rockville Pike, Suite 1000, Rockville, MD 20852; Phone 301-770-2920; Web: http://www.raps.org/ About Given Imaging Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given(R) Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 230,000 patients worldwide. The PillCam(TM) ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit://www.givenimaging.com.
This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission. DATASOURCE: Given Imaging CONTACT: Mark Gilreath, Given Imaging Ltd.; Fern Lazar, , or David Carey, , both of Lazar Partners Ltd., +1-866-GIVEN-IR Web site: http://www.givenimaging.com/ http://www.raps.org/
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