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In Seeking a Global Authoritative Source of Regulatory Information, Companies Look to Their Approaches to Affiliates

In Seeking a Global Authoritative Source of Regulatory Information, Companies Look to Their Approaches to Affiliates


By Adam Sherlock, chief of strategic development, ProductLife Group
Last Updated: 08-Sep-2014

Pharmaceutical companies are striving to conceive a global authoritative approach to managing regulatory information across the enterprise and as a result, are remodelling their relationships with their affiliate companies.

The emphasis is being driven by regulatory demands for more information and greater consistency as well as commercial drivers such as declining productivity, reimbursement and pricing pressures, and the growing need to acquire or partner in order to feed the pipeline.

To achieve the goal of globalising key processes and systems, companies need to not only manage the capacity, technical, process, and data challenges that will arise but also ensure affiliate acceptance of new processes and roles by means of extensive stakeholder engagement and change management.

Overcoming Challenges

The globalisation of major processes and capabilities is a main goal for many companies. Indeed, 49% of companies rate as a priority the improving of affiliates’ or regional offices’ abilities to enter and access regulatory information, according to a 2013 Gens and Associates survey on regulatory information technology priorities for 2014 that assessed 37 of the top 60 pharmaceutical companies.

Companies need to gain better oversight into the volume of their submissions to health authorities so that they can improve their allocations of resources. They need streamlined and clearly committed managements so they can know that the information being sent to the authorities is correct. And they need to ensure compliance with label changes by all affiliates affected by those changes.

In an effort to make sure their process and systems changes deal with pain points, many companies are conducting gap analyses to determine the scope and nature of those bottlenecks. One growing US biopharma company undertook a diagnostic analysis of what was happening across its European affiliates and found different operating models from country to country, different ways work was handled, and different skill sets of those doing the job. The company has been working to correct those irregularities so it can know that what is being delivered is consistent across Europe.

In its gap analysis, another large biopharma company found that the technology it used for communicating with its affiliates was inadequate for what the affiliates were being asked to do.

Improving Processes

In the adoption of new models for the exchange of information with affiliates, data migration and standardisation will be priorities. To achieve them, companies should have agreements about timeliness of data and must ensure the quality and robustness of the information uploaded into the system. Failure to prepare can massively undermine a project. One company that decided to take a global approach to its systems and processes underestimated issues around data migration and the vast amount of poor-quality, manually collected data it had to deal with.

Overall, there is a need to develop more-robust relationships with the affiliate network and to see to greater cohesion in terms of systems and information sharing. Many companies are working to improve operational efficiency across all affiliates while at the same time building strategic capabilities in key markets in order to improve their insights and understandings of those markets.

At the operational level, one multinational pharma company is developing a global solution to manage submissions and keep track of safety updates, global correspondence, global commitments, and related correspondence. It is a challenging endeavour—given the ever-changing regulatory climate and the high cost of implementing a validated system—but the company recognises the long-term benefits of having a global authoritative source of information.

From a strategic point of view, some companies are evaluating skill sets to make sure they have expertise at the national level so they can elevate the commercial needs of those markets and enhance relationships with health authorities. At one company, for example, affiliates in key markets will be having far more expansive roles to play with regard to regulatory intelligence and will be asked to understand and absorb the regulatory requirements in their countries and then feed that information back to headquarters so as to help the company adopt the most-progressive approaches to new products and solutions.

 An alternative way of improving consistency in regulatory information management at the affiliate level is to adopt hubs, or regional centres. Each hub would employ people from various countries in that region who not only are fluent in the relevant languages but also understand the finer cultural nuances of each country as well as the regulatory specifics of each market the hub serves.

Managing Change

The changes many companies are implementing require commitment to stakeholder support. To engage and involve affiliates in projects, one global pharma company has been holding regular affiliate and distributor meetings as well as regulatory intelligence forums to talk about problems and make sure headquarters addresses affiliates’ concerns: for example, are affiliates getting the information they need to conduct local assessments quickly enough? As a result, affiliates have become more engaged and are communicating different points of view to help shape the process.

Another global pharma company began by socialising its planned global system well before the intended launch, which demonstrated to affiliates what the system is designed to do and which included many in the testing. Those affiliate groups have since become champions for the rollout.

Change has an impact not only on systems and processes but also on roles, and taking that into account is equally important. Making affiliates feel more included in the company and more valued for their roles helps encourage them to embrace change, adopt new technology, and try new ways of working.

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Adam Sherlock –