We will manage global and local scientific literature search to establish the most significant source of information in monitoring the safety profile and the risk-benefit balance of medicinal products. This is particularly relevant in relation to detecting new or emerging safety signals or issues.
When you have submitted an MA (marketing authorisation) application, it is a regulatory requirement for you as the marketing authorisation holder of a medicinal product to perform regular searches of the scientific literature.
This is an important source of patient safety data which might contribute to the safety profile of your medicinal product.
Arex Advisor experts will:
-Set up, review and approve search criteria in the global literature database (PubMed or EMBASE).
-Select and review relevant scientific journals in the framework of local literature screening.
Adverse event management and case reporting
Effective PV systems for the Nordics
Local PV function, including medical information
PV training services
Lovisa Rosenquist
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
