Navigating the Challenges of Global Pharmacovigilance

Pharmacovigilance has never been more complex. The number of adverse event reports is growing exponentially. Regulatory markets are varied and constantly evolving. And with the rise of big data, there is a staggering amount of information to process. It is no wonder then that navigating this environment is a challenge for any company looking to expand access to their therapy worldwide. 

In this article, we outline some of the challenges you might face, including translations, key components of any global strategy, and provide an offer of support if you are looking to launch your drug in international markets. 

Growing Databases in Evolving Markets 

Europe and the US have two of the largest databases of adverse event case reports. In Europe, the EudraVigilance database holds information on 18.6 million individual case safety reports, with nearly 2 million submitted in 2020. The US database holds information on over 15 million.  

This quantity would seem surmountable if the regulatory landscapes were similar. But they have vastly different requirements. In Europe, all suspected adverse reactions need to be reported, compared with only suspected unexpected reactions for the FDA (Food and Drug Administration). A difference that can cause significant additional work for investigators and sponsors, and the addition of potential ‘noise’ reports to the product’s profile. 

Globally, there is an even wider variety of approaches. In some countries, such as Morocco, there are advanced systems, developed in partnership with the WHO (World Health Organization), where reports are handled through universities and hospitals and passed to national centers for processing. In other countries, particularly those that are low- to middle-income, robust systems are still in the process of being developed and so there may not be a defined, consistent reporting method across the region. 

As such, a flexible approach is required to operate within each system. This is even more important when it comes to translations. 

Why are Translations Crucial to Pharmacovigilance? 

Translations are about so much more than taking one language and converting it to another, particularly with the sensitive information contained in adverse event reports. Any ambiguity in context or accuracy could result in significant knock-on effects for the company, healthcare professionals, and patients in the reporting country, as well as others worldwide. 

Additionally, there is no standardized process for structuring the reports. As such, companies could receive handwritten doctors’ notes, graphs, diagrams, EKGs, you name it. In a variety of formats too, including PDFs, notepad files and even faxes. Add this to an expected turnaround of sub 24 hours and you have a mountain to climb. 

Welocalize Life Sciences shares a case study on how a global pharmaceutical company with over 100,000 employees in 90 countries tackled the challenge of a significant increase in pharmacovigilance translations worldwide.  

The Role of Digital 

Advances in technology are present in every aspect of our lives, from smartphones to smart cars. Pharmacovigilance is no different. Recently, authorities have been exploring new ways of managing reports, including remote inspections via conference calls and online document sharing. These were accelerated by the pandemic and have quickly evolved into everyday practice.  

Pharmaceutical companies and the agencies that support them have also been embracing new tech, with machine learning and process automation an increasing feature of translation management. This technique uses artificial intelligence to perform the heavy lifting of translations. Computers analyze and learn from millions of pieces of information to build libraries of phrases, medical terminology, and abbreviations.  

While it by no means replaces the eye of an expert linguist, the process can rapidly speed up and reduce the cost of translations for adverse event reporting. 

Machine learning is something we build into our processes at Welocalize, and by combining them with post-edits by subject matter experts and native-level speakers, we have helped our clients realize massive cost savings while achieving delivery rates of over 99%.  

Specialist Support is at Hand 

We can support you on the journey to expanding your pharmacovigilance to international markets. At Welocalize, we have over 20 years of experience in the pharmaceutical industry. With more than 250,000 native-level language specialists and a dedicated team of experts in global pharmacovigilance, we can offer accurate translations that meet the requirements of individual markets.  

Our automated workflow, which includes libraries of pre-approved terminology and abbreviations, means that translations can happen fast. We often turn around reports in less than 24 hours and sometimes even less than six, and our quality processes are guaranteed by five ISO certifications. 

If you are looking to expand your pharmacovigilance into new markets, we are here to help. You will have a dedicated team available to support you 24/7 and decades of expertise to ensure your reports are delivered on time. No matter the language. No matter the regulatory market. No matter the project. 

We will help you navigate the challenges. Get in touch with us to discuss your medical translation requirements.