Blog

PRISYM ID is a leading label lifecycle management solutions provider, with many year's experience implementing compliant solutions for our customers. Here we discuss best practices and interesting industry updates that we've come across.

 

Sharing Knowledge & Experience in Label-Specific Challenges

By Tim Fischer I recently took part and chaired an interactive session where executives and other medical device industry specialists came together to discuss challenges in a range of areas of labeling development, data and compliance.

Color Label Printing At Your Fingertips

By Vince Postil The idea of color printing labels on demand has been thrown around the medical device and pharmaceutical market for many years but in reality, most organizations rely on the traditional two-stage color label printing process they know – batch print and over print. But here lays the problem, huge amounts of label stock on the shelf can be costly and quite often wasted.

Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

By Mark Cusworth The clinical trial market is not only global, today it touches more markets than ever before. Increasingly, a key component of this is the need to comply with variable local language labeling requirements, not least in the safe distribution of medicines for clinical trials. With the global map for clinical studies now extensive, information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them.

Clinical trials: when the label became more significant than the drug itself…

By Mark Cusworth The importance of labeling in clinical trials gets very little exposure. However, as the global war for patients intensifies in an increasingly competitive trial market, and with subject attrition rates commonly shown to be between 15-20%, pharmaceutical companies are slowly discovering that the packaging of their products can be a key determinant of patient retention.

Top three challenges in clinical trial packaging and labeling operations

By Vince Postill 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.

Analyzing Best Practices in Lean Labeling for Global Efficiency & Regulatory Compliance

By Tim Fischer Last week (29th & 30th September), over 40 speakers from across the medical device industry came together to discuss the latest trends, issues and best practices in optimizing medical technology labeling and packaging.

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

By Tim Fischer 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.

UDI: FDA Draft Guidance

The US Food and Drug Administration (FDA) published its latest draft guidance on UDI, entitled: “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).”

Overcoming the Top 5 Challenges for On Demand Labeling

The increase in clinical trials complexity, coupled with the significant rise in trial drug costs, is having an industry-wide need for more flexible and cost-effective clinical supply operations.