Top Three Challenges in Clinical Trial Packaging and Labeling Operations

During our recent webinar ‘Future proofing your Clinical Supply Chain’, co-presented by myself and Jason James, Senior Manager, Labelling & Innovation, Bristol-Myers Squibb, we discussed some of the drivers for change in Clinical Research today as well as the impact of these changes on clinical trial supply chain, particularly packaging and labeling operations. Read More

Designing a Global Labeling Strategy, Given the Volatility of the Regulatory Climate

What is hot in the medical device industry?

Regulation around labeling for the medical devices industry has evolved significantly in the last 40 years. From the challenge being the creation of exact definitions for labeling in the 1970s, to the release of the Health Industry Barcode Supplier Labeling Standard in the 80s, and issues such as multi-language labeling, symbology and e-labeling in the 90s & early 2000s, today’s hot topic is UDI. Moreover, with the EU Council and Parliamentary Committees having signed off new Medical Device & In Vitro Diagnostic (IVD) regulations in June 2016, UDI is set to remain a hot topic years from now. Read More

FDA Regulations for Inspection

Ignoring the warning signs of non-compliance is no longer an option

Data shows that more than half of all FDA recalls of medical devices since Q1 2014 have been caused by packaging and/or labeling error. One of the most high profile recent examples was the Class I recall of a Peripheral Infusion System, where major mislabeling risked the incorrect use of the product by physicians and raised the potential for serious patient injury or death.

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UDI: An inconvenience or a chance for change?

It’s nearly three years since the original publication of UDI and the industry is well on track to achieving compliance. Indeed, April 2016 saw GUDID Labeler Accounts rise from 240 in October 2014 to 1275* only a year and a half later.

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