Monthly Archives: March 2016

Conferences, serialization

Sponsored: Tracking Serialization: 2016 Pharma Trace Market Trends

Tracking Serialization titleDo 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 →

EU FMD

EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

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iStock_000016455220_SmallerEver since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach.  The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by the U.S. federal government with the passage in 2013 of the Drug Supply Chain Security Act (DSCSA).

My friends always liked to point out how simple Continue reading EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary →

RxTrace Traceability Survey

Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report

Cover thumbnailThe final report of the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz is now available.  Download the full free report here.  With this year’s survey we attempted to get a glimpse of the progress toward the next deadlines of the Drug Supply Chain Security Act (DSCSA) from drug manufacturers, repackagers, wholesale distributors, 3PLs and dispensers.  Each of those different types of respondents were asked a different set of questions that were pertinent to their segment and their regulatory requirements under the DSCSA.

Frequentz.logoTake a close look at the results.  They reveal that Continue reading Sponsored: The 2016 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz, Final Report →

DSCSA, HDMA

HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil

iStock_000043324250_SmallerAccording to the HDMA, their Distribution Management Conference and Expo in San Antonio last week broke the attendance record at more than 500 attendees, but for the life of me, I can’t figure out why the number wasn’t double that amount.  When you compare the value you receive by attending this (or any) HDMA event with what you receive from any third-party event, well, there isn’t any comparison.  HDMA serves sizzling steak to their soggy puffed rice.  The reason is not just the quality of the speakers.  In fact, as “speakers”, they really aren’t any better at speaking than any other group of people, but it is who they are and what they know that makes the difference.  And just as important, who else is in the audience that makes these events so special.  It’s not just what is going on in the sessions, but it is who you meet and what you learn in the hallways and networking breaks between sessions.  I’ve said this before (see “Terminology: Track and Trace, and Pedigree”). Continue reading HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil →

DSCSA, EUDR

Drug Verification: EU Vs US

USvsEU flagsDrug verification is at the heart of most pharma serialization regulations.  It is the point at which someone in the supply chain or a patient uses the unique identifier on the drug package to determine that the drug is probably authentic, or definitely is not.  We can tell a lot about the intent of a given serialization regulation by looking at the specific language that determines by whom and when a unique identifier must be verified. Continue reading Drug Verification: EU Vs US →