Three ‘Ps’ for Implementing an Effective eCOA Strategy: People, Processes, and Plan

Jul 22, 2016

Clinical scientists have proven that the collection of clinical outcome assessment data with an electronic device improves patient compliance and delivers higher quality and more reliable data. The value of electronic clinical outcome assessment data for clinical trial claims, post-marketing safety studies and patient registries has become increasingly recognised by various stakeholders, including regulatory authorities and health economics outcomes research experts. D. Eek, C. Hall, S. Hooper, F. Wald and M. Wurm at ERT. ...

Read More

Why Do Pharmaceutical Glass Containers Break: The Underestimated Power of Strength Testing and Fractography

Jul 19, 2016

Most times in our life we use products with little understanding of how and why the packaging was selected. We usually don’t think about the design specifications of the container and its crucial role in delivering the contents safely. It is only when a problem occurs that we dig deeper into the selection criteria and science that were used to specify the packaging system. In the pharmaceutical industry, glass is by far the dominant material used for the packaging of liquid and lyophilised drugs due to its impermeability and chemical inertness for drug product stability, transparency for ease of inspection, ...

Read More

Automating the De-blistering Process

Jul 19, 2016

This article, by Luke Beedle, Sales Support Manager at Sharp Clinical Services, provides an overview of why de-blistering is required, what issues this creates, and how automated de-blistering technology can be implemented to improve run rates, increase efficiency, lower costs and help reduce risks to staff. Blister-packs are a very common means of packaging pharmaceutical tablets, capsules and soft gels. Such packs generally comprise a sheet of initially flat plastic or aluminium base material, in which is formed a series of wells. A tablet is inserted into each of the wells, the open ends of which are sealed by means ...

Read More

Improving Adherence: Packaging’s Synergistic Role in Delivery, Communication and Education

Jul 19, 2016

On 9 February 2016, the European Parliament and Council published the amended version of the Falsified Medicines Directive (FMD), detailing the characteristics of the security features that will be required on packaging for medicinal products for human use. It stated that both a unique identifier and an anti-tampering device will be mandatory, helping to address the current ever-growing threat of counterfeit medicines. Ian Lemon at Essentra reviews global counterfeiting. ...

Read More

Cold Chain Outsourcing: A Simple Answer to a Complex Question?

Jul 19, 2016

Pharmaceutical manufacturers are facing a new challenge. The recent patent cliff and the exponential growth in the development of high-value pharmaceutical products, biologically developed therapies and live vaccines in the last ten years, has resulted in a greater need for temperature-assured handling of drug product, from active ingredients to finished dosage form. This can be demonstrated by the fact that in 2013, seven of the top ten highest-selling pharma products were biologics, with global sales contribution from biologic drugs forecasted to jump from 23% in 2014 to 27% in 2020. Fiona Withey, Chief Executive Officer at PCI, shares her thoughts ...

Read More