Please watch a complimentary webcast featuring Virginia Herold from California Board of Pharmacy and Siobhan O'Bara from GS1 US as featured speakers who provide their perspectives on serialization and ePedigree regulations, and the industry's current state of readiness. PwC provides a brief overview on its approach for helping manufacturers, distributors, and pharmacies.
Please watch this complimentary webcast featuring Virginia Herold from California Board of Pharmacy and Siobhan O'Bara from GS1 US as featured speakers. During this webcast, Virginia and Siobhan provide their perspectives on serialization and ePedigree regulations, and the industry's current state of readiness. Additionally, PwC provides a brief overview on its approach for helping manufacturers, distributors, and pharmacies develop global serialization and ePedigree programs that address implementation challenges and prepare to comply.
California Board of Pharmacy's ePedigree legislation intends to secure the pharmaceutical and biotech supply chain by requiring that "drug manufacturers and repackagers...serialize drug products and initiate electronic pedigrees...and all participants in the supply chain...[should] immediately ready themselves to receive and pass electronic pedigrees." California's ePedigree law requires manufacturers to comply beginning January 2015, with a phased implementation across the value chain of distributors and pharmacies between 2015 and 2017.
But California's law is not the only legislation that companies will need to comply with. Currently, Congress is debating similar legislation that it hopes to pass this year. Also, countries / regions such as Brazil, South Korea and the European Union will require some form of serialization between 2014 and 2017. In summary, manufacturers, distributors and pharmacies will soon be faced with a multitude of regulations which unless complied with will disrupt their ability to distribute products for sale.
So why all the concern? After all, manufacturers have been bar coding products for a long time, so serializing the saleable unit of the typical pharmaceutical or biotech package should be relatively easy. However, maintaining the aggregated unit to lot information from the end of the packaging line to the warehouse is not as easy, and creating the ePedigree has only been piloted to date. Furthermore, the required IT solution architecture is complex, and the industry is still wrestling with the standards and platform required to manage ePedigrees.
With all these challenges ahead, now is the time for all organizations involved in the healthcare value chain to prepare! Please watch this webcast to be part of the ongoing discussion regarding serialization and ePedigree.
Participation in the live webcast qualifies for 1 CPE credit.
Please note that CPE credit can only be given to individuals who remain logged into the LIVE webcast and respond to the polling questions provided during the webcast. If you are viewing this webcast in a group, everyone in the group can receive CPE Credit. Also, those who dial in via telephone are NOT eligible for CPE credit. Please note that this is a NASBA (not PwC) requirement.
If you have any questions concerning continuing professional education (CPE), you can find answers here to frequently asked questions concerning CPE webcast participation.