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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2018-05-04 | From Abbey Rd. to Blockchain Blvd.

Do you remember when the Beatles released Rubber Soul?  Not being alive in 1965 meant I was unable to experience this first hand, but as an avid fan I've done some research so bear with me for a minute.  The album arrived as a shock, it was unlike anything the public had heard before.  It was a dramatic departure from their previous material and the band's maturity was perceptible in their songwriting and lyrical content.  While fans initially struggled to wrap their heads around what they...

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2018-04-13 | Blockchain may be ready for healthcare, but is healthcare ready for blockchain?

 

There is a sharply polarized view within the healthcare industry as to whether blockchain is the holy grail or Dante’s 1st circle of hell.  This truly hyper-partisan view of a technology leaves us all scratching our heads on what to believe. 

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2017-11-22 | Buyer Beware: The Truth About Counterfeiting This Holiday Season

 

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2017-11-03 | Serialisation Readiness Requires Working with Knowledgeable, Experienced Partners
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2017-10-20 | The Lexicon of Serialization: Terms You Need to Know

 

Serialization forms the new basis for the ongoing effort to secure the supply chain—most significantly the pharmaceutical supply chain, but also increasingly in other sectors. However, it is only the foundation on which other technologies are built to add this sought-after security. Serialization goes far beyond placing a number on a box.  These associated technologies, and the terms used to describe them, are explained here.

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2017-09-08 | Diversion in the Pharmaceuticals Market

The opioid crisis in the United States has been described as an epidemic requiring urgent action on the part of government, law enforcement, health advocates and other stakeholders. A substantial portion of overdose deaths result from opioids produced by reputable manufacturers for legitimate medical purposes that have been redirected to illegitimate use. This transfer of a legal substance to illegitimate or illicit use is known as diversion, and represents a major challenge in the...

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2017-07-28 | Our View: A Different Approach to Pharma's Counterfeiting Problem

 

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2017-03-28 | Data Sharing Required by European Hub; Pharmacies to Verify Before Dispensing

Drug manufacturers who market drugs in Europe will need to begin applying unique identifiers and an anti-tampering device to their packaging by February 9, 2019. Most companies are already aware of these well-publicized requirements of the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR). Systech offers packaging line management and serialization solutions that will allow you to easily meet these requirements. But you might not be aware of the other big...

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2017-03-17 | The Global Serialization Marathon

By Avi Chaudhuri, PhD, Senior Global Partner

We are currently in the middle of a regulatory marathon—one created to meet the country-by-country guidelines for drug packaging throughout Europe, USA, and several other countries. At Systech, we care about this because the technology platform of choice to accomplish regulatory compliance has been our primary focus for more than twenty years. Systech has been the global leader in serialization-based product traceability ever since the US FDA...

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