Katarina Andersson
Senior consultant
B Sc in Pharmacy
katarina.andersson@regsmart.se +46 (0)730 – 41 68 05
Katarina is a senior advisor in pharmacovigilance, with long experience as a pharmaceutical inspector, pharmacovigilance (GVP), from the Swedish Medical Products Agency (MPA). At MPA she spent twelve years as an inspector, of which six years as Head of the GVP/GCP group of inspectors.
More about Katarina
She has extensive knowledge in pharmacovigilance and has been a delegate in the Pharmacovigilance Inspector Working Group at the European Medicines Agency for several years.
The work as inspector has included inspection of national sites as well as European sites and in countries outside EU, e.g., India and USA. The Marketing Authorisation Holders (MAH’s) inspected have ranged from small MAH’s to multinational companies.
In addition, she has 13 years of experience from the pharmaceutical industry in clinical trials and pharmacovigilance.
With long experience in pharmacovigilance, Katarina can provide valuable insight in achieving efficient and well-functioning pharmacovigilance systems in compliance with the regulations.
At RegSmart Katarina supports customers in different assignments such as QPPV/ deputy QPPV, pharmacovigilance audits and inspection readiness.