2019-02-18 | What’s All the Buzz About Counterfeit Wine and Spirits?

In partnership with SafeProof.

Bootlegging alcohol didn’t get left behind in the Prohibition Era. In fact, according to a 2014 report by the World Health Organization, unregulated alcohol makes up 25% of all consumption worldwide. But what are the implications of fake alcohol? Why should everyone from consumers to manufacturers to government entities care? Let’s take a look at the facts.

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2019-01-07 | Systech UniSeries rises to the repackaging challenge

Drug repackagers face unique challenges under the Drug Quality and Security Act (DQSA), driven by their distinctive position in the pharmaceutical supply chain. One major US drug repackager needed a solution with a wide breadth of features and comprehensive configurability to get in compliance with DQSA so they reached out to Systech for assistance.

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2018-12-03 | The Genie is Out of the Bottle ... My Thoughts on the Marijuana Business Conference in Las Vegas

First, allow me to set the stage with some facts:

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2018-10-24 | Counterfeit Bazaar: An Inside Look

Imagine going to town and seeing your favorite brand of makeup at half the cost. Sound too good to be true? It is.

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2018-10-02 | Reducing the Complexity of Global Pharma Regulatory Compliance

First and foremost, a successful serialization program involves far more than just placing serial numbers on packaging -- regardless of the market. However, pharmaceutical companies that distribute in more than one country face significant regulatory compliance complexity, with each additional market adding another layer of challenges. Regulations differ between markets, and can change often enough meaning regulatory professionals must be prepared to adjust processes, procedures and filings...

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2018-09-06 | China Announces New Drug Traceability Regulations.

In late August, the China National Drug Administration (CNDA) posted three new draft guidance documents detailing a proposed National Drug Regulatory Information Standard and Traceability System. Chinese versions of the drafts are available now but the agency is requesting feedback from stakeholders and the public to be submitted by September 20, 2018. Final versions are likely to appear soon after that.

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2018-08-21 | Egypt, India and Pakistan Delay Their Pharma Serialization Deadlines

In 2017, the largest market for pharmaceuticals—the United States—delayed enforcement of their key pharma serialization requirement. The revised deadline for serialization and verification here is November 27, 2018, one year later than originally specified by Congress in the Drug Supply Chain Security Act. A few months before that delay was announced, Brazil withdrew their entire regulation, changed their law, and published a more reasonable timeline that would result in full serialization...

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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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2018-06-29 | Blockchain : Insanity or Genius?

Vincent Willem van Gogh is remembered as the quintessential tragic artist, having been relatively unsuccessful during his life and plagued by mental illness. While staring at the gardens out the window of the Saint-Paul asylum, could van Gogh even begin to comprehend the idea that some of his final works would be among his most famous and fetch prices upwards of $80M at auction? Could he even understand that his life, his techniques and body of work would be studied and treasured? Could he...

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2018-06-22 | False reassurance—the real danger behind India's new pharma serialization proposal

India is on the cusp of introducing a new serialization program for domestic pharmaceutical products. Indian officials have designated this new initiative as a track and trace program though it appears from media reports that the proposed mandate will instead be aimed at creating a consumer-based authentication program. The idea is to print a unique serial number on drug packages so that consumers may authenticate the product via an SMS- or call-enabled mechanism to verify the code.

There...

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