Life sciences is a challenging sector to operate in. Competition is tough, and success requires a combination of business agility and control.
But although life sciences is subject to stringent and ever-changing regulation, it can have a tendency to manage content for international markets in an inefficient and error-prone way.
When content on packaging or labelling needs to change, each country must oversee its reviews. Visibility is limited, and the correct master content and relative status of each country’s version are not always clear.
This has become unsustainable. The sheer volume of patient-facing content that manufacturers and distributors are required to maintain for each product, in each market, is increasing exponentially. Simultaneously, safety and regulatory requirements are multiplying and changing all the time too. The result is an increased risk of incomplete or inaccurate information, leading to late-market introduction because compliant labelling or patient literature isn’t ready.
There are many different factors that can drive a change to labelling, including; changes to product safety information, new or changed local regulatory requirements, and ongoing product updates due to an increase in the agile development methodology.
The situation is becoming more, rather than less challenging. Increased focus on improving patient safety internationally means countries that once accepted English as the language for product labelling and instructions for use, now require local translations. Similarly, organizations can no longer get away with imposing the most commonly spoken versions of a language (such as Spanish); they’re now expected to reflect each market’s variations – so that Mexico, for instance, gets its own translation. This is increasing the workload associated with creating compliant patient information.
Adding to the market’s dynamics are the continued elevated levels of merger and acquisition activity, which are further intensifying the demands on content management - as brand names, copyright details, and corporate identity change. These changes must be reflected across all external content and often require re-submission and registration with different international notified bodies – a process that can take many months in some countries.
Increasing complexity and costs
If content is not managed in a structured, centralized way, complexity, risk of error, and inflated costs can grow exponentially. This situation is magnified if responsibility for local versions is left to in-country distributors or affiliates, and can lead to retrospective labelling, a common burden for companies marketing drugs internationally.
Failure to produce correct, compliant labelling and other patient information can delay market entry, or worse, result in costly product recalls, or pose a threat to patient safety. Mistakes can lead to reams of pre-printed content (e.g., stack upon stack of instructions-for-use leaflets sitting in warehouses, ready to ship out with products) having to be pulped.
The way forward - a centralized approach to international labelling
Everything points to the need for life sciences companies to adopt a systematic, centralized approach to international packaging and labelling to reduce labour, shorten time cycles, reduce risk and cost, and substantially improve market agility.
This is how best to approach it:
Agree content ownership - centralized content management begins with content ownership, which should be brought under a single team - for instance, technical communications. Appointing someone to own all content (including translated versions) brings clarity and an opportunity to drive change from a single focal point.
Establish a single, unified content asset database – hosted centrally, it is advisable to host this in the cloud (by way of a software-as-a-service model), to allow authorised teams ease of access anywhere in the world.
Data centres across different geographic regions – this ensures distance is no barrier to the system’s performance and that latency is minimised. This added advantage of using an externally hosted content management system is that companies don’t need to manage, administer or support the technology themselves (it’s all done for them).
A life sciences-specific system - given the very specific and complex needs of global life sciences content management, it is worth looking for a system that has been designed specifically to cater to the nuances of this highly regulated environment.
Manage content at a component level - a system that can manage content at a component level, rather than at a document level, is recommended. This allows approved components, or other digital assets to be simply plugged into different types of output. This ready repurposing reduces the overall scale of the task and the risk of mistakes being introduced each time changes are required.
The benefits of such an approach are well proven. Major international labelling updates involving thousands of different pieces of output have been shown to shrink from two years to six months. Desktop publishing costs can be halved across all languages, and the typical international content lifecycle meanwhile can be reduced from 28 weeks to as short a time as nine weeks.
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