Lene Havsteen

Lene Havsteen has worked in the regulatory affairs field since 1993. Lene began their career as a Provisor at Humlebæk Apotek, followed by a similar role at Steno Apotek in 1995. In 2001, they joined the Danish Medicines Agency, Medicines Licensing as a Regulatory Project Leader, where they were responsible for DCP, MRP, renewals, variations, product information, user test, and labelling. Lene was also a member of the Nordic Packaging Group. In 2018, they moved to Coloplast as a Vigilance Specialist. In 2020, they joined Thermo Fisher Scientific as a Sr. Regulatory Specialist and is currently an Associate Director Regulatory Affairs at Biograil™.

Lene Havsteen obtained a Master in Pharmacy from Københavns Universitet - University of Copenhagen in 1993. In 2007, they obtained a Diploma in Pharmaceutical Regulatory Affairs from Medicademy. In April 2022, Lene obtained an ISO 13485 og 9001 certification from Fonden Dansk Standard. In May 2021, they obtained a Clinical Evaluation for Medical Devices in Europe and International approach certification from MEDTECH DENMARK.