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On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation. This new law eliminated the patchwork of existing state laws and it also provided new regulations for compounding pharmacies. That’s big news for patient and product security.
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TraceLink Inc., the leader in pharmaceutical serialization, track and trace and supply network towers for global Life Sciences, announced today that Brian Daleiden, TraceLink's Vice President of Marketing, will speak on the US Drug Supply Chain Security Act (DSCSA) at the 4th University of Wurzburg Anti-Counterfeit Conference taking place May 26-27, 2014 in Wurzburg, Germany. During the conference focused on Strategies against Falsified / Counterfeit Medicines, Mr. Daleiden will review the new DSCSA law which phases in starting January 1, 2015 for companies across the pharmaceutical supply chain.
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Laser Application Technologies has received a thumbs up from the US Food and Drug Administration for its Natural Light Labeling system, designed to get rid of stick-on produce labels.
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CLEVELAND — Traceability is becoming a bigger factor for medical devices and other plastic products, largely because of the rise of the Internet, which has made it easier for counterfeit goods to be made and sold.“Bad things can happen if counterfeit goods get into your supply chain,
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The Malta Medicines Authority said today that no falsified products labelled as Herceptin have reached the local market in a legal framework. Products originally labelled as Italian Herceptin 150mg vials, have been stolen probably in Italy and later re-introduced illegally into the supply chain in some countries, including the UK, Finland, Germany, Austria and Sweden, the government said.
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European authorities recently warned that stolen vials of Roche's cancer med Herceptin were showing up across the continent, some containing little or no active ingredient. Now they say the thefts were not isolated incidents, but commissioned by an organized crime group in Italy.
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Tweet Scoop.it Tweet Gemalto, the world leader in digital security, announces that its Machine-to-Machine (M2M) Software as a Service (SaaS) solution is providing remote PC monitoring and real-time maintenance for ADLINK, a global provider of embedded industrial computing products and services. ADLINK industrial PCs are used to manage and control business processes and assets such [...]
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The Drug Quality and Security Act, or DQSA, signed into law in November 2013, created a national serialization and traceability system that aims to increase the safety of the U.S. drug supply. The system, which will be phased in over 10 years, requires pharmaceutical manufacturers to place a unique serial number on individual packages of prescription drugs, allowing each to be authenticated and electronically traced as it moves from the manufacturer to the wholesaler to the pharmacy.
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From
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Wakefield, MA (PRWEB) May 01, 2014 -- TraceLink will fully support the newly announced HDMA 856 Advance Ship Notice designed to facilitate implementation of the Drug Supply Chain Security Act by members of the pharmaceutical supply chain. The HDMA 856 ASN format will be one of several options provided by TraceLink for the interoperable exchange of DSCSA compliance documentation across the supply chain.
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Counterfeiters, beware! Scientists are reporting the development of a new type of inexpensive barcode that, when added to documents or currency, could foil attempts at making forgeries.
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Over the next two years, Eli Lilly will be strengthening its efforts against counterfeiting with a $110 million investment in a new serialization program for its drug packages.
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Understanding the full impact of lot level reporting and determining when companies need to aggregate serialized item level data to the case are two areas that are hazy for many. There are a lot of different interpretations. Maybe it is time to take a look at the requirement to serialize product from a different perspective. Look at the supply chain issues that companies face today. Are there opportunities to provide an ROI on the serialization investment while keeping an eye to the future in order to support compliance?
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UDG Healthcare has released the results of a pilot programme which shows the benefits that the introduction of ‘Track and Trace’ technology could have on Ireland’s immunisation programmes. The outcomes of the study highlight where significant improvement could be made to the current system, particularly with regard to patient safety and effective programme delivery. The pilot was conducted in partnership with the HSE National Immunisation Office.
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FDA is committed to protecting consumers from potentially dangerous drugs, including those that are counterfeit, stolen or tainted. We are taking steps to create a system that will help identify and trace certain prescription drugs as they are distributed within the United States.
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Food traceability technology is one approach to bridging the gap between safety and compliance
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Brazil has announced a new drug serialization and traceability system. The National System of Drug Control proposal published this week by ANVISA essentially provides for serialized drug identity and supply chain-wide drug traceability from production to dispensing where each node in the supply chain maintains their own database of product and transaction information.
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As the medical field advances, lasers play a central role in the evolution of medical procedures. What once required prolonged hospitalization and recuperation can now be done in a fraction of the time and without overnight hospital stays. Lasers are at the forefront of this change. Lasers have long been used to mark, weld and cut medical devices and surgical instruments. More specialized applications include: making cuts to the micron, highly resolved biocompatible markings that enable traceability of instruments and implants, and spot welds with heat affected zones that are virtually invisible.
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FDA’s approach for securing the drug supply chain was clarified last month when the agency issued final guidance on a serialized standard numerical identifier (SNI). As with the agency’s draft guidance of January 2009, the agency said it should be viewed as recommendations and its current thinking on the topic.
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Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
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One of the greatest challenges that supply chain leaders face when launching global data standards initiatives within their organizations is convincing the C-suite to provide support for the effort. While many recognize that standards can improve operational efficiency, reduce costs and enhance patient safety, there is scarce data demonstrating that healthcare organizations – both on the buy and sell sides of the supply chain – can achieve a quantifiable return on their investments.
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Some 2 to 5 percent of all international trade involves counterfeit goods, according to a 2013 United Nations report. These illicit products — which include electronics, automotive and aircraft parts, pharmaceuticals, and food — can pose safety risks and cost governments and private companies hundreds of billions of dollars annually.
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From
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Some 2 to 5 percent of all international trade involves counterfeit goods, according to a 2013 United Nations report. These illicit products—which include electronics, automotive and aircraft parts, pharmaceuticals, and food—can pose safety risks and cost governments and private companies hundreds of billions of dollars annually.
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From
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AWS customers love the sheer variety of services available to them; they’re not wild about how hard it is to assess what they’re paying. Amazon says Cost Explorer is here to help.
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In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce...
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At its stand (Hall 8A/Stand F05-G03), Marchesini Group will show five lines - two blister lines, a sterile line, a line for syringe packaging and a line for Track and Trace, the technology for pharm
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Curated by Beeyond
BEEYOND is a consulting company in the field of disruptive innovation, accompanying established companies on out-of-the-core growth strategy, from creation of new concepts to product launch. Reach us at: contact@beeyond.fr.
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