Professor Per Helboe is an expert in regulatory affairs and provides strategic advice to clients on quality and regulatory-related product matters. He is a Professor in Regulatory Affairs at the University of Copenhagen, Faculty of Health and Medical Sciences and was Senior Director and Head of the Licensing Division of the Danish Medicines Agency from 2001 until his retirement in 2011.
Professor Helboe was instrumental in formalizing cooperation between the Danish Medicines Agency and China’s State Food and Drug Administration (SFDA), with Denmark being one of the first EU countries to enter into this type of agreement with China. He was also active in the ICH harmonization process, serving as an EU representative on quality issues, and acted as the EU ICH Coordinator for Quality between 1995 and 2001.
Professor Helboe was actively involved in setting the EU standards on requirements for the quality part of marketing authorization dossiers. From its founding until 2001, he was a member of the CHMP Quality Working Party and chaired the group for two years. He has also been involved in several working groups on issues relating to the digitalization of licensing procedures in the EU.
SFL Regulatory Affairs & Scientific Communication Ltd.