In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act (DSCSA). It’s already been a long journey, but this is only the beginning. Companies can’t even take a break. In just one year the wholesale distributor saleable returns requirement will force manufacturers to either capture aggregation data or connect to a Verification Router Service (VRS)—or both! The year after that, Continue reading From Serialization to Full Traceability: 2018 Outlook On Compliance
I just helped IQPC update their printable global pharma serialization regulation map. Get a copy here. Things change around the world pretty often so it’s important to update resources like this frequently. The information for most of the existing countries was updated and I added a few new countries. It’s a great resource to print and pin up on your office wall, or the company bulletin board to keep everyone focused on the approaching deadlines around the world. And it looks great too! Continue reading Sponsored: Newly Updated Global Serialization Regulation Map
The IQPC PharmaTrace Summit will be held on June 4-6 in Princeton, NJ. In preparation for the event, IQPC asked four industry veterans to respond to a set of forward-looking questions to get a glimpse of the future of serialization and track & trace in the US pharma supply chain. The four include: Continue reading Sponsored: Interview With Four Pharma Supply Chain Thought Leaders
Back on June 30, 2017, the U.S. FDA extended the product identifier requirements under the Drug Supply Chain Security Act (DSCSA) to November 26, 2018 due to insufficient industry readiness. This gives the industry an extra full year to make sure their solutions are fully integrated and tested. Are you ready? Are you done? Even those who would have been ready this November are likely to have more to do to make sure their start-ups go smoothly. What about your European Falsified Medicines Directive (FMD) strategy? That’s right around the corner too. Continue reading Sponsored: Bio/Pharma Serialization and Traceability Summit 2017
There is a rare alignment of events that will happen in the first week of December that is so special that you need to put it on your calendar. There are two important pharma serialization events that will occur in the Washington DC area and anyone with a serious interest in that subject should attend both. These events line up perfectly to allow you to travel once, and spend four days that will solidify your understanding of the issues and opportunities embedded within the Drug Supply Chain Security Act (DSCSA) in particular, and pharma serialization in general. Continue reading Sponsored: Don’t Miss These Back-To-Back Pharma Serialization and Tracing Events
The 4th Pharmaceutical Traceability Forum will occur on November 30 through December 2 in Philadelphia. Two of the top speakers will be Matt Sample, Senior Director, Secure Supply Chain from AmerisouceBergen, one of the “Big-3” wholesale distributors in the United States, and Christopher Howell, Senior Director, Global Engineering and Technology from Patheon, one of the largest pharma contract manufacturers in the U.S.. Recently, IQPC conducted an interview of both of these supply chain thought leaders. Get a copy of the interviews here. Continue reading Sponsored: Interview With Two Pharma Supply Chain Thought Leaders
Do you know what situation your peers’ businesses are in, and what they’re working to? To find out just that, IQPC polled their network of pharmaceutical serialization professionals and got responses from representatives of over 20 companies.
The results? Most find data storage and management to be their biggest issue, citing ERP systems as some of their biggest investments in 2016 and going forward. It follows that over 50% of those we polled are either implementing their strategies in multiple sites or already done and thinking beyond compliance.
IQPC also asked about their biggest inhibitors, their current and future budgets, and their experience with international compliance. If you want to find out what your peers think about these topics, you can download the survey report, or meet them on-site at the Pharmaceutical Traceability Forum, May 23 – 25 in Philadelphia. Use the discount code PT_RXTRACE to get 20% off the standard price! Continue reading Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends
It is time to look at the better healthcare supply chain conferences coming up this fall. This year the focus will be on the Drug Supply Chain Security Act (DSCSA) and the Unique Device Identification (UDI) final rule implementations. For the DSCSA I think we will see presentations aimed at both the immediate 2015 data exchange requirements and those aimed at the 2017 serialization requirements, but I also expect to see presentations aimed at “second generation” data exchange—those based on GS1’s recently updated Electronic Product Code Information Services (EPCIS) standard. After meeting the initial data exchange requirements for Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) in January, companies will need to begin preparing for the second generation using EPCIS (see “DQSA: Getting To Electronic Transaction Data Exchange”). That transition will likely occur over the next three years. Continue reading 2014 Fall Conference Season Preview