Karen Gram Education M.Sc. (Pharm) 1972, has been employed since 1973 in Ferrosan A/S, and transferred to Novo Nordisk A/S in 1987. Ms. Gram has been in product development – oral preparations – for 20 years; heading Clinical Packaging department for 5 years and introduced usage if IVRS to Novo Nordisk back in 1993 to manage a big phase 3 programme. Ms. Gram has worked in the Clinical Supplies area during her entire professional career and is now working as a principal specialist coaching and training colleagues in Clinical Supplies. Ms Gram was a member of the first ISPE IP COP Steering Committee for 5 years, and returned to the Steering Committee in 2008, leading the Booklet Label Task Team.