Tag Archives: free

My Handshake With Germany

Our industry is international by nature.  Protecting patients from counterfeit drugs is partly a humanitarian mission and partly a business.  Consequently, I don’t worry much about who is looking for information on RxTrace.  I have happily fielded queries from Russia, China and even Iran, countries who are not always political “friends” of my beloved country. 

But what if a counterfeiter is seeking information Continue reading My Handshake With Germany

Sponsored: Pharma Traceability

May 22-24, Hotel Del Coronado, Coronado, CA

Pharmaceutical serialization and traceability laws continue to be developed all over the world.  In any one market, it takes several years to progress from the initial stirrings to the publication of full, workable regulations.  As we have seen, several countries have had to take a few steps back, make adjustments and then move forward again (see “Brazil Gets Rational With Their New Pharma Traceability Law” and “China’s Retreat From Pharma Serialization: Will This Become A Global Trend?”).  In fact, I think those countries that do, will end up with a much better approach.

What that means to you is Continue reading Sponsored: Pharma Traceability

Sponsored: The Season For Label Redesign

With the approach of pharma serialization deadlines all around the world, this is the season for label redesign.  The addition of new unique identifiers in 2D barcodes and human readable forms—often without removing existing linear barcodes—requires knowledge of the pharma labeling regulations in the target markets as well as artwork skills (see “DSCSA: Label Artwork Heartaches”).  The problem is, serialization doesn’t apply to just one product, it applies to all prescription drugs marketed in the target market.  That threatens to cause Continue reading Sponsored: The Season For Label Redesign

Dawn of HDA’s Origin, The Key to DSCSA Compliance

This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July.  The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website).  That is, it is a database of master data wrapped within a cloud-based service. 

Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance

Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance

Pharma companies are spending a boat-load of money to put serial numbers on their drug packages and homogeneous cases, and collecting aggregation data for the wholesale distributors.  And in every one of those companies, their leadership is asking, “What can we do to get some value, beyond compliance, from our investments?  Can we sell someone some data?  Can we get some new business advantage?  Can we get some new insight into our processes or into the operation of the supply chain?” Continue reading Sponsored: Brand Protection: The ‘No Brainer’ Value, Beyond Compliance

Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!

One of my favorite conferences each year is the annual Unique Device Identification (UDI) Conference put on by the Clarion Group on behalf of the Food and Drug Administration (FDA).  I am happy to sponsor the event each year, and I try to attend when I can.  

As an educational authority on UDI, the 9th annual UDI Conference will Continue reading Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!

Sponsored: Monitor Your Product. Manage Your Brand.

Dear Colleague,

We recognize that counterfeit and grey market products pose tremendous risks, both to consumer safety and to your business’ bottom line. The 6th Pharma Anti-Counterfeiting & Brand Protection Summit takes a comprehensive approach to understand the latest regulations for the DSCSA to remain compliant and uphold quality through brand protections plans, anti-counterfeiting strategies, and effective partnerships.

Key Highlights for 2017 include: Continue reading Sponsored: Monitor Your Product. Manage Your Brand.

Brazil Gets Rational With Their New Pharma Traceability Law

Last week, Brazil President Michel Temer signed law number 13,410, which amends law number 11,903 from 2009, their original pharma serialization and tracing law.  The effect of the new law on the old can be seen here.  The problem for me is that I don’t read Portuguese, so I must rely on Google Translate to translate these texts.  This results in an unofficial translation that has a few imperfections that are obvious, even to non-Portuguese readers, but it appears to be not bad. Continue reading Brazil Gets Rational With Their New Pharma Traceability Law