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A new service offering is designed to help medical device companies ensure the success of their innovations. Foster-Miller Inc.’s new Innovation Express is a series of services designed to help companies identify, target, design and manufacture innovative products. It uses the expertise of Foster-…
Policy Manager, Medical Consultants Network Inc.’s new comprehensive software, includes the company’s entire content library. Policy Manager represents MCN’s first-ever marriage of its 16,000 policies and procedures with Compliance 360 software. Together, the offering provides hospitals a complete…
Mollie Shields-Uehling is SAFE-BioPharma Association’s new president and CEO, company officials recently announced. Shields-Uehling was principal of Shields-Uehling Associates, an international public affairs company. She previously served in various leadership positions with Bristol-Myers Squibb,…
The Pharmaceutical Research and Manufacturers of America recently launched an advertising campaign aimed at America’s senior citizens about the safety risks of importing prescription drugs from foreign countries. The campaign includes the launch of a new Web site, www.buysafedrugs.info, which acts…
The National Committee for Quality Assurance recently added clinical performance information to its online Health Plan Report Card. The “Living with Illness” report addition shows how effectively health plans treat patients in four areas: diabetes, cardiac care, asthma and mental illness. The…
Chemical inventory systems deliver real-time and accurate information about inventory status to ensure greater cost control while supporting validation requirements, according to a recent in-depth white paper from ChemSW Inc.“Chemical Inventory Systems Enable Pharmaceutical Pilot Plants to…
The recent publication of a magazine article about the growing black market for counterfeit drugs prompted the president and CEO of the Pharmaceutical Research and Manufacturers of America to issue a warning. The article, published in the June 20 issue of Forbes magazine, details the growing…
Health and Human Services Secretary Mike Leavitt recently announced of a national private-public collaboration to advance the use of electronic health records and interoperability through established standards. The American Health Information Community will aid in the nationwide transition to…
P-Wave Inc. and Promium recently formed an alliance to offer environmental labs a unique document and data management solution. The partnership integrates LabCORE, P-Wave’s laboratory document management system, with Promium’s ELEMENT data system, a laboratory information…
SAFE-BioPharma Association recently announced that INC Research has become its first contract-research organization member. INC Research will deploy the SAFE infrastructure to equip its internal teams and physician investigators with electronic identity standards. “We adopted the SAFE digital…
Chemir Pharma Services recently changed its name to Azopharma in response to its extensive growth and commitment as a contract pharmaceutical services provider. Azopharma is a FDA-registered and cGMP-compliant research and development organization that supports the development and…
A recent benchmarking study examines best practices in pharmaceutical launches, and includes case studies and insights from some of the industry’s biggest companies.The study, performed by Best Practices LLC, includes best practices from Merck & Co., Eli Lilly & Co., Wyeth, GlaxoSmithKline…
ClinPhone Group Ltd. recently announced the appointment of four new business development managers, part of the company’s plan to strengthen commercial operations in the United States. ClinPhone is a specialist clinical technology organization that works with leading global biotechnology and…
Cognex Corp. recently released ProofRead, an optical character verification (OCV) system that ensures pharmaceutical label information is printed correctly.With ProofRead, manufacturers can ensure the right data, lot or product code is printed, the right labels placed on the right products, and the…
The International Society for Pharmaceutical Engineering is gearing up for its first global good manufacturing practices conference, to be held Sept. 19–21 in Prague, Czech Republic. The conference will focus on important regulatory and industry insights from expert presenters from all over the…
According to research from the Pharmaceutical Research and Manufacturers of America, the use of an electronic system that authenticates individual packages while they’re on the supply chain protects both the industry and patients. The use of radio frequency identification chips (RFID) on…
The International Society for Pharmaceutical Engineering is marking its 25th anniversary with a full schedule of activities commemorating its contributions to innovation in pharmaceutical manufacturing. The ISPE was founded in 1980 with the primary purpose of providing education, networking…
The International Society for Pharmaceutical Engineering announced the availability of its newest technical publication, “GAMP Good Practices Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.” The guide is a user-friendly manual that covers the appropriate management of…
MedMira Inc. has recently achieved registration to ISO 13485:2003.MedMira, a provider of rapid flow-through diagnostic technology, reports that the standard is formally recognized by the European Commission as a key quality assurance requirement for the CE Mark approval for medical devices. ISO…
(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) announced the availability of its newest technical publication, “GAMP Good Practices Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.” The guide is a user-friendly manual that covers the…
Firstlogic Inc., a provider of enterprise information quality and mail-automation software, recently announced that Dendrite International has started using its data quality solutions to improve customer information management for Dendrite’s pharmaceutical and life sciences clients. Dendrite is a…
As the nation tightens its borders against possible terrorist attacks, it risks undermining those efforts by allowing the importation of non-FDA-approved prescription drugs. This was the conclusion of a report issued by Giuliani Partners, a firm headed by former New York City Mayor Rudy Giuliani. “…
The Food and Drug Administration has determined that endoscopic trocars reprocessed by Vanguard Medical Concepts Inc. are substantially equivalent to new instruments and has cleared the company to resume selling them. Vanguard voluntary took its trocars off the market last fall, pending an FDA…
A new study by Best Practices LLC contains performance metrics from which pharmaceutical companies can perform gap analyses to assess manufacturing performance and identify improvement opportunities. “Pharmaceutical Manufacturing: Cost, Staffing & Utilization Metrics,” contains the following…
AMR Research recently released a study that predicts that the cost of compliance for companies will reach $80 billion over the next five years. The firm also estimates that regulated organizations will spend close to $15.5 million on compliance-related activities in 2005. Although an average…