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
Tag Archives: GS1
The Aggregation Hoax and PIA
Pharmaceutical manufacturers should be aware that there is a lot of uninformed misinformation going around out there lately about the need for them to supply aggregation data to their trading partners to meet the Drug Supply Chain Security Act (DSCSA) (for more on aggregation, see “Pharma Aggregation: How Companies Are Achieving Perfection Today”, “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”, and “Does The DQSA Require Manufacturers To Provide Aggregation Data? Survey Says…”). In my view, prior to 2023 you can collect aggregation data if you want to, but don’t let anyone tell you that the DSCSA requires you to. It doesn’t. And I also encourage you to be skeptical of any claims that wholesale distributors will not accept your product anytime soon unless you provide them with aggregation data. Feel free to Continue reading The Aggregation Hoax and PIA
GS1 Ratifies Updated Versions of EPCIS and CBV
GS1 just updated their website with the newly updated versions of their Electronic Product Code Information Services (EPCIS) and Core Business Vocabulary (CBV) which were ratified by the GS1 Board on Monday. Both carry the new version number “1.1”. The two standards are separate but intertwined because the core business vocabulary is used within the various EPCIS events, so the two standards are likely to always be updated at the same time, as in this case.
This update marks the culmination of several years worth of hard work by the team, co-chaired by Michele Southall of GS1 US and Andrew Kennedy of FoodLogiQ, facilitated by the great Gena Morgan of GS1 US and with Ken Traub serving as the Editor for both standards documents, under the GS1 Global Standards Management Process (GSMP).
WHY THIS IS SIGNIFICANT FOR THE PHARMA SUPPLY CHAIN
This is a significant event for pharma supply chains around the world, but particularly for Continue reading GS1 Ratifies Updated Versions of EPCIS and CBV
Randomization—An Interview with Ken Traub—Part 5: Other Approaches
This is the last of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:
- GS1 Serial Number Considerations
- Properties of Randomization
- Threat Analysis
- Algorithmic Approach
- Other Approaches to Randomization (this essay)
This week Ken talks about other approaches to serial number randomization. – Dirk. Continue reading Randomization—An Interview with Ken Traub—Part 5: Other Approaches
Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization
This is the second of a five part interview with Ken Traub, GS1 standards expert and independent consultant, on GS1 serial number randomization. The full series includes essays covering:
- GS1 Serial Number Considerations
- Properties of Randomization (this essay)
- Threat Analysis
- Algorithmic Approach
- Other Approaches to Randomization
This week Ken introduces three properties of randomization. — Dirk.
Continue reading Randomization—An Interview with Ken Traub—Part 2: Properties of Randomization
Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations
Over the next two weeks I have a very special treat for RxTrace readers. It is an interview with Ken Traub, GS1 standards expert and independent consultant. The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.
Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization. I’ll have more to say about why in a follow-up essay after this series is over.
Because the interview with Ken covers the topic so thoroughly, it is long. That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing. But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays. Read sequentially, they contain the complete interview. The subtopics covered by those essays include: Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations
The Future of Healthcare Supply Chain Security
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
- In the U.S.:
- In the E.U.:
- The Falsified Medicines Act (FMA)
- The Harmonized Unique Device Identification Framework
- The anticipated Delegated Acts related to the FMA
Continue reading The Future of Healthcare Supply Chain Security
Sponsored: Transatlantic Alignment
Happy Martin Luther King day! Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K.. Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk.
Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has been proposed, debated, boosted and resisted for a very long time. The labyrinthine twists and turns have been examined in near real time on RxTrace and I won’t revisit them here. However, the passing of the Drug Quality and Security Act (DQSA) late last year opens a new chapter. It means greater transatlantic clarity of future compliance requirements and (whether intentional or not) it also brings near synchrony of some key deadlines. Continue reading Sponsored: Transatlantic Alignment
