Adapt to Survive

Article featured in European Biopharmaceutical Review: Harnessing automated content checking using technology that can compare and accurately spot and highlight anomalies – at high-speed across huge batches of content assets – can reduce the time taken to verify output by as much as 85%. Peter Muller explains this and other trends currently preoccupying biopharmaceutical organisations.

Form and Substance

Article featured in Innovations in Pharmaceutical Technology:  Forward-thinking companies are treating the current hiatus around IDMP as an opportunity to quantify the data preparation task ahead. Inevitably, organisations will need help to complete the groundwork, but they are not yet at a point where an all-encompassing product is possible. In any case, how content or data will ultimately be used is secondary at this point – the priority is ensuring that the data is correct, complete and clean.

Change Management

Article featured in International Pharmaceutical Industry: The life sciences industry is in a state of flux for a whole series of reasons, which can largely be traced back to shifting market dynamics and growing regulatory rigour. In a conservative and inevitably slow-moving industry as this, it can be hard to keep up with the changes. This article explains the five biggest sources of disruption to pharma companies.

 

In Imperfect Harmony? What will Brexit Mean for Regulatory Harmonisation

Article featured in European Pharmaceutical Manufacturer: The UK’s separation from the EU could have implications for regulatory harmonisation, and increase administrative workloads at a time when responsible teams are already overstretched and experienced talent is hard to find. Dr Jutta Hohenhörst of Schlafender Hase asks what impact this could have on IDMP preparations. 

Food Labelling

Article featured in Inside Food: In May the FDA announced new guidance on food labelling, mirroring a move in Europe to improve transparency and safety for consumers. The aim is to provide more detailed health and nutrition information and make this more prominent, but the new requirements will add to the workload for manufacturers and their partners. 

The Great Brain Drain

Article featured in International Pharmaceutical Industry: The life sciences industry is drowning beneath a sea of new regulations and directives. As well as being immensely demanding from a risk management perspective, the associated administration is detracting from core activities. 

Swerving the Talent Trap

Article featured in Pharma Exec: Soaring regulatory requirements are tying up RA and QA talent: skilled and experienced people who must now devote hours to mind-numbing administrative tasks to ensure updated product information is accurate and compliant. This is an inefficient use of costly resources, and it undermines job satisfaction by failing to channel professionals’ intelligence.