Lene Thrane

Director/Sr. Regulatory Affairs Specialist

Lene is a highly experienced senior regulatory affairs specialist with more than 35 years of experience from the international pharmaceutical industry. For the majority of these years, Lene has acted as global regulatory lead for drug development projects in early and late clinical phase development, ensuring requirements from all countries have been dealt with during the drug development phase and being successful in bringing a product all the way from early development phase to launch and maintaining it on the global pharmaceutical market (Europe, USA, Canada and Japan).

Lene’s regulatory experience lies primarily within the clinical area, where she among other has prepared and lead scientific advice procedures and developed labelling documents as well as coordinated and reviewed module 2 documents for license applications.