GIM and PIM

With several PIM submissions now complete, Matthias Heyn, VP EMEA Solutions at SDL, explains how organisations are tackling the translation challenges in the PIM arena.

GIM is fast moving up the Life Sciences boardroom agenda. In spite of the fact that English is broadly accepted worldwide for key business processes in the industry, local language information is a mandatory requirement for most content passing through worldwide regulatory application processes. Local content is also needed for targeting patients for sales, marketing and research.

With XML rapidly turning into the dominant platform for content, a number of initiatives at both the government and corporate levels have emerged to take advantage of these evolving XML standards. They focus on XML supporting technologies and procedures for a single base language (English).

Life Sciences organisations in Europe are increasingly managing their electronic regulatory submission processes using a Centralised Procedure (CP), governing 23 languages. Europe’s electronic regulatory submission process is being developed around the PIM standard, based on recommendations from the European Medicines Agency (EMEA). Designed to support more than 20 languages, PIM defines an electronic XML-based submission process that reduces the complexity of the communication between regulator and applicant for each submission. It also accelerates the time (predictability) from submission to decision.

Product information

PIM makes it significantly quicker and easier to manage and exchange product information through the structuring of the information and its exchange by electronic means. PIM also improves the quality and consistency of the published product information. Ultimately, PIM leads, in the mid-term, to a significantly shorter approval process when compared to the old model.

Initiatives to meet the demands of PIM are in place. Indeed, several approaches have already begun. Some companies implement separate labelling systems for each regulatory XML standard, for example an SPL system for the FDA and a PIM system for EMEA. Others are currently working on labelling systems capable of generating the various regulatory XML standards from an independent ‘core’ labelling XML presentation. In the last case, we find companies that built their labelling system around their own internal standard capturing the way they have structured their data sheets, or companies who are adapting a vendor proposal for a ‘unified’ or ‘master’ label presentation.

Whatever strategy companies choose, in the case of PIM, all of these approaches are only solving half of their issues. All current labelling system initiatives are supporting the authors of labels and the managers who centrally manage the submission. They do not provide the necessary environment for efficient translation production and efficient translation quality control involving the critical stakeholders in their local operations. Let’s remind ourselves that a PIM submission consists to 95 percent of translations. This is why PIM and GIM go together.

GIM (Global Information Management) systems with their translation reuse mechanisms address these requirements. GIM is a new class of enterprise solution that provides the essential business strategy and tools for enabling Life Sciences organisations to manage the escalating requirements for local language delivery. Many companies in the industry have invested in content management and web management solutions to manage the content creation, approval and publishing processes. Whilst these systems can manage and deliver localised content, once it has been created they do not have the capability needed to manage the localisation process. GIM solutions augment a company’s existing solutions to provide the capability needed to manage the process of taking approved content and localising it appropriately for a global audience. Effective GIM can dramatically reduce processing time whilst reducing localisation costs.

Moving down the PIM and GIM road

GlaxoSmithKline (GSK) is one organisation tackling the challenges of making PIM submissions using the CP in Europe. The company currently has 27 approved Centralised Licenses and several submissions under review. The sheer volume of European labelling documents also gives some insight into the challenge facing the company: each product may appear in two formulations, in four different strengths. Then each of the four strengths may be presented in three pack sizes – each of these requiring translated content on the outer packaging, on the blister and on the product itself.

Andrew Marr, PhD, Director of e-Regulatory Development, Global Regulatory Operations at GSK, outlines the company’s approach to the CP: “Translation is a major and routine activity for GSK and efficient translation management is critical to the successful use of the CP. Our key challenges are to ensure rapid translation turn-around, with no compromise being made on quality.”

In GSK’s CP, product information is translated in house, under the responsibility of the local affiliate regulatory affairs staff. Local language speakers have a strong knowledge of scientific/medical English and a good relationship with the local agency for dialogue on linguistic review comments. The product information is reviewed in English under ‘Opinion’. Translations are then filed that should be exact translations of the English, with QRD templates covering structure, headings and standard statements. PIM plays a vital role here: supporting the matching of structures between all languages.

Three years ago, GSK’s German affiliate undertook a pilot with a Translation Memory solution from SDL – a system that memorizes translations (pairs of source and target language sentences) in a central database. The Translation Memory is used to research references of how something was translated in the past and retrieve exact matching or similar sentences to speed-up the creation of consistent translations.

This led to the creation of a translation memory from English/German for centrally-approved products. The results in terms of speed and quality improvements, says Marr, were very encouraging: while the traditional translation raised 26 comments, only two were raised on translation memory translation. Marr: “Used alone, PIM offers the benefits of re-use, the elimination of redundancy and the fact we have a single output with all content. Translation memory alone avoids the need to re-translate text. Put them together though and you have a compelling, synergistic solution: elimination of redundancy, avoidance of formatting effort and translation use in context.”

Global XML

It’s a similar situation at Genzyme, who is adopting the CP like GSK. Unlike GSK, Genzyme does not have local resources and expertise dedicated solely to translation services. Indeed, information management in 24 languages is a significant challenge for the company.

Genzyme relies on a centralised GIM strategy, using external translation services and local internal staff reviewing content. Raun Kupiec is the company’s Director of Regulatory Affairs. He says: “Each regulatory professional has a combination of tasks – including submission, managing clinical data and conducting trials – and translation management needed to be fitted in among these tasks. The translation approval workflow can be very complex for a single regulatory person to manage.”

Genzyme is currently conducting its first approved PIM pilot using structured XML. This approach is allowing the company to reuse content in multiple formats, reducing the duplication of effort in creating content. “There’s no doubt that the marriage of PIM and XML will short-circuit the steps in the translation workflow. Simultaneously, it will reduce the margin for error. The bottom line is that the Genzyme pilot is experiencing cost-savings in the translation phase and in the editing phase,” says Kupiec.

A compelling case for PIM and GIM

The business case for delivering drug labelling information to regulatory agencies using PIM in conjunction with GIM is compelling. PIM establishes standards for delivering normalised, multilingual content and creating submissions using the standards. The caveat is that PIM solutions need to address the authoring, storage, translation and publishing environment conflicts inherent in a global information management process.

GIM solutions reuse content assets across documents and projects, saving weeks of authoring and translation work, thus accelerating regulatory compliance and product rollouts. GIM solutions also optimise the accuracy and consistency of information provided. By enabling simultaneous worldwide product launches and by automating best practices for GIM, Life Sciences companies are able to improve revenues and reduce the costs of compliance.

BIO

Matthias Heyn is VP Solutions Europe at SDL International. He specialises in consulting companies and organisations for their global information management initiatives. He successfully consulted the first European electronic submissions based on PIM for GSK and Genzyme. Heyn is specialised in regulatory compliance of multilingual submissions, global branding, simultaneous product shipments and translation production environments.