Novo Nordisk is a global healthcare company with leadership in diabetes care. Headquartered in Denmark, Novo Nordisk employs approximately 43,000 people worldwide. Besides products for diabetes the company develops and market products for other serious chronic diseases, such as haemophilia, growth disorders and obesity.
Since November 2017 the company has monitored its products on the additional monitoring list through the data retrieved from the EudraVigilance database, in addition to the regular surveillance of safety data in own database. Novo Nordisk currently has 6 products on the additional monitoring list.
The presentation will focus on the Novo Nordisk’s experience with monitoring of adverse event data via the EudraVigilance database, the benefit, usefulness and limitations in the current set-up.
The current set-up is based on manual evaluations of EudraVigilance data and seen as a supportive tool to signal detection of own safety database.
I have almost 20 years’ experience working with pharmacovigilance, both from pharmaceutical companies and from the Danish Medicines Agency. As background education I have a master’s degree in pharmacy, a post-graduate diploma degree in Pharmacovigilance from UK and a post-graduate degree in Regulatory Affairs from DK.
During my career, I have worked both with safety surveillance and safety operation related tasks, and both with products in development and marketed products, and thus have very broad experience within pharmacovigilance.
In my current role at Novo Nordisk A/S as a Safety Surveillance Principal Specialist, I am involved in different process improvement activities within the area of Global Safety. One of our focus areas is the further development of the signal management tools and methods we apply in our work.