Louise Vinberg Hansen

Meet the Expert

Louise Vinberg Hansen DVM, PV Principal Consultant at Insife

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Life Sciences and Health Care are among the most heavily regulated sectors. In recent years – especially, following the global roll-out of COVID-19 vaccinations – Pharmacovigilance (PV) has become a focal point for politicians and lawmakers. After the global pandemic, authorities realized that the collection, processing, and reporting of adverse side effects are crucial to secure patient safety and maintaining public and patients’ trust. 
Therefore, aligning PV regulation with national and global regulatory requirements is essential. Therefore, Insife has created a Regulatory Intelligence team led by Louise Vinberg Hansen to do global monitoring of Regulatory PV requirements. 

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The path to Pharmacovigilance

Louise Vinberg Hansen has a degree in Cand. Med. Vet. from the Faculty of Life Sciences at Copenhagen University. Initially, she thought her career would be as a veterinarian practitioner in an animal hospital, but she landed in the Danish Health and Medicines Authority as a Pharmacovigilance Associate. Using her academic, strategic, and technical skills quickly set her on a different path. 

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This position led on to the private sector when she was employed as a Drug Safety Advisor, at Actavis, a position which was later upgraded to PV Specialist focusing on regulatory compliance. 
The direction was set, and in the following years, with increasing specialization and establishment of her senior expert status, Louise Vinberg Hansen was employed by companies like Novo Nordisk and Ferring Pharmaceuticals. Her ability to run PV optimization projects, technical know-how, configuration of the Oracle Argus Safety database, (including products, licenses, studies, reporting rules, workflows, case priority, etc.), and performing gap analyses of new requirements gave her the expertise needed to be a leader in Regulatory Intelligence.

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Insife

Louise Vinberg Hansen joined Insife in 2021. First as a Senior Consultant, and in 2022, she was promoted to PV Principal Consultant, working in the Regulatory Intelligence area with global regulatory reporting requirements, the PROHALO service, and as an Oracle Argus Safety database SME. 
Technical expertise plays a part in her position with system implementation upgrades, validation, testing, and specification updates. Nonetheless, her primary focus is on legislation, compliance, and regulatory requirements enforced by Health Authorities. According to Louise, the level of complexity is increasing:
“I’m part of the Regulatory Intelligence team covering regulatory reporting requirements for more than 120 countries with a key focus on ICSRs and Device reporting requirements. We ensure that the solution complies with global regulations, which requires extensive research and inquiries to national Health Authorities”.
Regulatory Intelligence involves monitoring and screening regulatory updates, ensuring that any impact on the PV safety systems is reviewed and shared with relevant stakeholders. 

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A Change in Regulatory Practice

According to Louise, there has been a change in national lawmakers’ focus on PV, becoming more complex and demanding at a local level and generally less willingness to align globally. 
“In the past, EMA and FDA were the key players in defining the PV regulatory requirements. Today, we are seeing more and more national Health Authorities changing their practices by introducing regional requirements which are not necessarily aligned with FDA and EMA”. 

Consequently, increased research, monitoring, and, to some degree, diplomatic abilities are needed in her job. Perseverance is a key skill in her research strategies.
“Safety Systems need to be able to handle these regional requirements, which can be a challenge for the industry, especially countries that are reluctant to provide their national laws and regulations in non-native languages. In less developed parts of the world, official written material may not even be available or no national PV regulations have been written. Obtaining these crucial insights may include extended negotiations and outreach efforts to find the right government official documents”. 

To Louise, this is a responsibility she gladly takes on:
“It is essential to our clients that with PROHALO, they are assured compliance with national regulations. Given the conditions just described, it is difficult for many companies to allocate the necessary resources to carry out these very time-consuming tasks of collecting, monitoring, and analysing essential documents. 
I find that my work has a large degree of purpose”.

To contact Louise or find out more about Insife’s Global Regulatory Intelligence service (GRIP) email grip@insife.com.