Dirk Rodgers

Dirk Rodgers
Dirk Rodgers is a Regulatory Strategist where he writes regularly in an exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has posted over 400 essays on these specific topics and is the author of the book “The Drug Supply Chain Security Explained” (Amazon). A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. In 2002 he became employed by Cardinal Health, one of the big 3 U.S. drug distributors, where he studied many approaches to applying serialization and track & trace technology to solve supply chain integrity problems and also improve supply chain efficiencies. In 2003 he represented Cardinal Health on Accenture’s seminal Jumpstart project, an early pharmaceutical supply chain RFID pilot. Dirk has served on HDA, NCPDP, EPCglobal, GS1 and GS1 US technical and standards work groups. He served as co-chair of the GS1 EPCglobal Drug Pedigree Messaging (DPMS) work group and the GS1 Network Centric ePedigree (NCeP) work group, among others.
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Recent Posts

2018-07-18 | Russia Flirts with A ‘Crypto Code’

A few months ago, the government of the Russian Federation adopted Order Number 791-r, which appears to have significance for pharma serialization there. The primary deviation from the pharma serialization specification that has dictated the government pilot in Russia since early 2017 is the addition of two new data elements to the datamatrix barcode on secondary packaging. For the pilot, the datamatrix barcode contained:

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2018-03-16 | 3 Important New DSCSA Resources

  

From now through November 2020, the deadlines for meeting the Drug Supply Chain Security Act (DSCSA) happen every year. The pace of change has accelerated and companies need to remain vigilant to stay compliant. Fortunately, there are three important new DSCSA resources that became available in the last two weeks.

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2018-02-23 | The 2017 GS1 US Barcode Assessment

Last month, GS1 US published a report on a DSCSA barcode assessment they conducted last year with two of the largest wholesale distributors in the US, AmerisourceBergen and McKesson.  The goal of the assessment was to take a “snapshot” of pharmaceutical manufacturer progress toward meeting the serialization requirement of the Drug Supply Chain Security Act (DSCSA) by analyzing drug packages actually in the market.

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2018-02-19 | Serialization is Only the First Step

Pharmaceutical manufacturers are working non-stop to get the serialization systems in place necessary to meet the USA DSCSA mandate going live this November, and the EU FMD mandate going live the following February of 2019.  If serialization projects aren’t in full flight at this time, there is a significant chance that a manufacturer will not meet the deadline, not be compliant and not be able to distribute product in those geographies.

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2018-02-12 | The Systech DSCSA Manufacturer Strategy Guide

 

It’s difficult to keep up to date on all the milestones and requirements of the Drug Supply Chain Security Act (DSCSA).  Because the law contains 10 years’ worth of deadlines and detailed requirements for every segment of the supply chain, it’s easy to get lost and miss what your company should be working on now.  Fortunately, most companies need only focus on what is coming up next, while keeping an eye on the long-term requirements.  Toward that end, Systech has just introduced the first...

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2018-01-12 | Russia Sets Date for Full Serialization

 

President of the Russian Federation, Vladimir Putin, signed a new law the last week of December 2017 that is important for pharmaceutical manufacturers distributing products to or manufacturing in Russia.  It establishes January 1, 2020 as 

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2017-11-17 | The HDA Traceability Seminar 2017

The Healthcare Distribution Alliance (HDA) Traceability Seminar is always a great event to find out about the current industry response to the Drug Supply Chain Security Act (DSCSA), and ideas for where it is headed in the future.  This year was particularly valuable for those who attended.  Sessions included a DSCSA update from the FDA, HDA perspectives on DSCSA guidance, manufacturer perspectives on serialization, an update on HDA’s Verification Router Service (VRS) and other technology...

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2017-10-27 | GS1 Healthcare Conference Recap

 

Systech is a member and strong supporter of GS1 Healthcare, the global group that promotes standardization in healthcare product and entity identification.  On October 17, 2017 in Chicago, GS1 Healthcare held their fall Global Healthcare Conference.

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2017-09-29 | Complications of Europe's Falsified Medicines Directive

Now let’s look at some of the complications for drug manufactures when meeting the Europe's Falsified Medicines Directive (FMD), and particularly the Delegated Regulation.

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2017-09-22 | Europe’s Falsified Medicines Directive (FMD) Explained

 

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