Serialisation – Commercial Versus Clinical Perspectives

Jan 8, 2016

There is a significant amount of activity in the pharmaceutical industry in mobilising to meet the requirements of recent Drug Quality and Safety Act (DQSA) legislation, passed by the United States Congress with the intention of limiting the spread of counterfeit or otherwise falsified medicines to patients for prescription drug products. Justin Schroeder, Executive Director, Marketing, Business Development & Design at PCI Pharma Services (PCI), reviews serialisation from the perspective of commercial versus clinical. ...

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Relating Tamper-evident Technology to Market and Product Fraud Risk

Jan 8, 2016

To make a pharmaceutical folding box tamper-evident may be as simple as taping the flaps. This method will reduce some less severe types of fraud, such as taking a blister out of the box, at a shop or warehouse, without notice. However in high-risk environments, fraudsters may elaborate fancy methods to harvest even security- sealing labels on original packaging for reuse. Dr Marietta Ulrich-Horn at Securikett, together with devoted clients, works on a systematic approach to close the loopholes in tamper-evident technology. ...

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Redefining Value in the Pharmaceutical Industry and the Role of Packaging

Jan 8, 2016

Providing safe and efficacious treatment of disease is no longer sufficient for new drug products. Today’s medicines must address an unmet need or be a much better solution than existing products. They need to increase patient adherence, be easy to use, prevent counterfeiting and tampering, be traceable and of course be cost- effective. Guy Tiene MA, Director of Strategic Content at That’s Nice LLC – Nice Insight, provides an overview of the pharmaceutical industry and the role of packaging. ...

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Serialisation: The Great Challenge for the Pharmaceutical Industry – Considerations on China

Dec 17, 2014

Most of the big pharma players have been working during the past years to implement projects linked to serialisation, despite the uncertainty regarding concrete rules, data and specific regulations. Marga Romo of Nekicessa discusses China: the next deadline for serialisation in China is 2015, with the well-known 128C code, different from the expected data matrix that is likely to be implemented in Europe; and this code is becoming a nightmare for the serialisation-responsible people in the companies, due to technical problems related to length and grading. ...

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