The brand integrity/product security world is heating up again, and not just for those focused on Brazil, China, Turkey and the global regulatory landscape. In June, the US White House released the “2010 Joint Strategic Plan on Intellectual Property Enforcement.” (A report by the IP Enforcement Coordinator, Victoria Espinel) Two key recommendations are: (more…)
Posts Tagged ‘ePedigree’
White House Takes Firm Stand on Pharma Pedigree
Tuesday, August 17th, 2010Oracle Launches Major Pedigree and Serialization Product
Tuesday, August 17th, 2010Since we do a lot of pedigree-related work, and deal with many of the vendors in this space, we had an opportunity to get an early look at Oracle’s Pedigree and Serialization Manager (OPSM) solution. OPSM was designed to create and manage serial numbers, record and transmit serial number hierarchies and create pedigrees. OPSM was designed to comply with both document model (California) and centralized server (European) methods of pedigree reporting and to be extensible to meet future pedigree formats and data standards. Additionally, OPSM has an open web services architecture that should allow for additional features, such as product authentication, analytics and enhanced supply chain visibility.
RFID is Dead…at the Unit Level in Pharma
Monday, April 26th, 2010Dirk Rodgers, formerly of SupplyScape and one of the foremost experts on track and trace/brand integrity, published what we’ve all been waiting for…realization that RFID is Dead (at the unit level for pharmaceuticals) on his RxTrace blog. I say “that we’ve all been waiting for” as, since the initial discussions of Florida’s pedigree law and certainly during the California pedigree debates, RFID has been mentioned as a “preferred method” by both governments and wholesalers. While debate has raged, my guidance to clients has been clear…RFID should be considered at the case and/or pallet level but not at the unit level unless there is a significant business case.
Pharmaceutical Track-and-Trace Makes it Big
Monday, April 5th, 2010On April 1, pharmaceutical Track-and-trace made it to the Op Ed page of the New York Times…and it wasn’t an April Fools’ joke!
Katherine Eban, of Dangerous Doses fame, and J. Aaron Graham, former chief security officer of Purdue Pharma, who launched one of the first RFID-enabled Track-and-trace pilots for OxyContin in 2004, teamed up to write a piece on the risks of illegal (counterfeit, diverted) pharmaceutical product and the benefits and costs of track and trace technologies designed to protect against such illicit activity. The Op-Ed was written in response to a $75 million theft of psychiatric drugs (Prozac, Cymbalta, Zyprexa) from Eli Lilly’s Enfield, CT warehouse.
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