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Statit Releases Health Care-Industry Software Solution
Statit Software Inc. recently released Performance Indicator & Management Dashboard (piMD), a new approach to measurement and analysis for the heath care industry. Statit reports that a review of current software options for health care executives revealed a need for a system that would enable…
New Health Care System Would Require Quality Reporting
The American Health Quality Association has thrown its support behind the creation of a comprehensive system to measure and report on the performance of health care organizations and practitioners. The Institute of Medicine, a health care trade group, recently proposed creating the new system,…
ANAB Announces Accreditation Program for Recycling Industry
ANSI/ASQ National Accreditation Board (ANAB) is developing an accreditation program for the recycling industry. The scheme, called the Recycling Industry Operations Standard (RIOS) is a comprehensive, integrated standard based on ISO 9001 and ISO 14001. It includes six components: general…
Missouri Health Care Organization Receives Quality Awards
Missouri health care provider SSM Health Care recently received several quality awards. The awards were presented by the Excellence in Missouri Foundation, which administers the Missouri Quality Award and Missouri Team Quality Award programs. SSM St. Joseph Health Center, St. Charles; SSM St.…
ISO Publishes Guidance for Health Care Sector
The International Organization for Standardization recently published a new version of International Workshop Agreement 1, which provides additional guidance for the health care sector. IWA 1:2005 has been made more user-friendly by incorporating improvements suggested by health care providers…
TÜV America Appoints New Medical Health Services Manager
Karen Brozowski was recently appointed to the position of East Region medical health services product manager for TÜV America Inc. Brozowski has worked for 20 years in the quality and regulatory industry. Most recently, she was TÜV America’s group vice president of regulatory affairs and quality…
PharmaEdge Summit Announced
The 2006 PharmaEdge Summit will examine the unprecedented pressures and public scrutiny facing the pharmaceutical manufacturing industry. The event will he held Jan. 22–24 at the Myrtle Beach Marriott Resort at Grande Dunes, South Carolina. Delegates will discuss benchmarking, best practices and…
Brooks Software Forms Life Sciences Team
Brooks Software recently formed a new engineering, services, marketing and sales team specifically focused on the life sciences and medical-device manufacturing industries. The team, led by Vice President of Regulatory Compliance Joseph Vinhais, will provide strategic direction and leadership to…
PCMA Discourages Drug-Patent Extensions
Citing concerns about bioterrorism preparedness, the Pharmaceutical Care Management Association has discouraged the extension of several prescription drug patents currently being discussed by Congress. Congress is currently being lobbied by drug companies to extend the patents on some drugs, but…
Pharmaceutical Companies Preparing for Avian Flu Outbreak
The Pharmaceutical Research and Manufacturers of America reports that PhRMA member-companies are helping world governments prepare for the possibility of an avian flu pandemic.An important line of defense in the event of an outbreak will be antiviral drugs such as Tamiflu, a Roche product, and…
BioMed Realty Trust Acquires Two New Properties
BioMed Realty Trust Inc. recently acquired two new properties, one in San Diego and one in the San Francisco area.The company’s new site in San Diego is it ninth in that area. It purchased the 28,704 square-foot facility for $8.5 million from Isis Pharmaceuticals Inc. Isis, a public…
Blue Cross/Blue Shield of Minnesota Receives Medicare Drug Contract
Blue Cross/Blue Shield of Minnesota was recently awarded a contract with the Center for Medicare and Medicaid Services to offer Medicare Part D prescription drug coverage through its Northern Plains Alliance, a group of six Blue Cross plans throughout the upper Midwest. It will extend drug coverage…
Genilogix Releases Validation Accelerator with e-Signature
Responding to a growing demand for automated testing tools by life-sciences companies, Genilogix LLC recently released its Validation Accelerator with e-Signature. The device is designed to work with Mercury’s TestDirector for Quality Center product, which enables clients to leverage optimal power…
U.K. Medicines Trade Balance Dips
The balance of trade in medicines for the United Kingdom dipped over the first half of 2005. The Association of the British Pharmaceutical Industry reports that there was a 14-percent drop in the trade balance over the first six months of 2005 as compared with the first half of 2004—from 1.693…
Clinical Trial Data Collection Conference Announced
The Optimize Clinical Trial Data Collection and Exchange conference will be held Oct. 24–25 at the Sheraton National Hotel in Arlington, Virginia. Kelly Vaillant, Amgen Corp. global head of clinical data management, will serve as the conference chairman. Valliant and Tim Dietlin, Campbell Alliance…
ISPE Releases Definition of RABS
Because of the great confusion about restricted access barrier systems (RABS), the U.S. Food and Drug Administration and the International Society for Pharmaceutical Engineering have released a definition paper to elucidate industry professionals on the topic.The paper includes key elements of RABS…
Pharmaceutical Companies Donate for Hurricane Relief
American pharmaceutical companies have donated millions of dollars in cash and medicines to the Gulf Coast region for victims of Hurricane Katrina. The assistance is being sent to both public and private relief organizations. The donations include: $2 million in cash and $4.5 million in…
PhRMA Launches New Web Site
The Pharmaceutical Research and Manufacturers of America recently launched a new, more patient-friendly Web site. The new site includes stories of patients who are successfully fighting serious illnesses, provides information about the research and development of new medicines, details facts and…
TÜV America Offers Certification Services to New Japanese Pharmaceutical Affairs Law
TÜV America recently announced its ability to offer medical device certifications to the new Japanese Pharmaceutical Affairs Law (PAL). Effective since April 1, PAL monitors how medical devices are marketed and regulated in Japan. It regulates and classifies medical devices by their level of risk.…
Accellent Receives Registration to ISO 13485
A recent companywide registration to ISO 13485 marked Accellent Inc.’s commitment to continuous improvement and zero defects, company officials recently reported.The standard applies specifically to the medical device industry and requires continuous improvement and reliable product quality. “This…
Health Care ISO 9001 Hybrid Audit to be Performed
The Accreditation Commission for Health Care Inc. and SGS Systems & Services Certification will jointly perform the health care industry’s first audit that combines clinical best practices with ISO 9001. The audit will be performed on Southern Pharmaceutical Corp. in October. The organizations…
New Online Training Offers "A La Carte" Options
Medical Consultants Network Inc. recently announced a different approach to pricing and delivering its interactive lessons. By offering flexibility, its users can access any specific training course with a la carte options.MCN Training Solutions represents a new business model for training, with…
PhRMA Announces Advertising Guidelines
The Pharmaceutical Research and Manufacturers of America (PhRMA) recently adopted a new set of guidelines for its members’ direct-to-consumer advertising activities. PhRMA’s board of directors gave final approval to the Guiding Principles in July, but they only become effective in January 2006. The…
Schering-Plough Appoints New Quality VP
Jacqueline Crew was recently appointed vice president of pharmaceutical sciences quality at the Schering-Plough Research Institute. In her new role, Crew is responsible for leading worldwide quality assurance activities for SPRI in support of global clinical supplies manufacturing, pre-approval…
Online Quality Compass Now Available for Health Plan Comparison
The National Committee for Quality Assurance recently released its first online version of Quality Compass, a health plan comparison tool. Quality Compass includes accreditation and HEDIS results on more than 250 commercial health care plans. It allows employers, health plan administrators and…

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