Hilde Kloster Smerud was until recently Head of the Regulatory Affairs Department in the SMERUD Medical Research Group, and is now working as QA Manager with the same company. She joined SMERUD in 2000 after completing her pharmacy degree at the University of Oslo and Mount Sinai School of Medicine of New York University. Her experience covers pharmacovigilance and basic European regulatory affairs services, including also price and reimbursement applications in the Nordic countries. During recent years, strategic consulting to small biotech companies has been the main working area, including in particular preparation of clinical development plans and regulatory strategy.