Please join us on Tuesday, September 17, 2013 at 2:00pm ET (11:00am PT) for a 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 will provide their perspectives on serialization and ePedigree regulations, and the industry's current state of readiness. Additionally, PwC will provide 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 join us for this webcast to be part of the ongoing discussion regarding serialization and ePedigree.
To register for the webcast, please click the registration link to the right or left of this page.