Per Helboe acts as professor in regulatory affairs at the University of Copenhagen. He also works as a consultant and he is member of the Advisory Board of SFL Ltd a Consultancy in Basel, Switzerland. Per has over a lifetime worked at the Danish Medicines Agency. Starting as an analytical chemist he changed over the years to more managerial functions. He retired in 2011 as the senior director of the Licensing Division. Per was active in both the European Pharmacopoeia (vice chair 1992-95) and in the CHMP Quality Working Party (Chair 1993-1995). He worked in the ICH process from1991 and until 2001. From 1995 to 2001 he was the EU ICH Coordinator for Quality.

Since 2002 Henrike Potthast is working as biopharmaceutics expert at the German regulatory agency. Before joining the agency she was employed at the Central Laboratory of German Pharmacists (ZL, Eschborn, Germany) for about 14 years. There activities comprised research projects in pharmacokinetics, bioavailability, bioequivalence, in-vitro dissolution, and cell culture (Caco-2) investigations. She is member of the EMA Pharmacokinetics Working Party (PKWP) and the EUFEPS Network Steering Committee on Bioavailability and Biopharmaceutics. She is a Temporary Consultant to WHO and active as EU Deputy topic leader in the ICH M9 harmonization process on BCS-based biowaivers.

Diana van Riet-Nales has a doctor degree in pharmacy and a master degree in epidemiology, She is working as a senior assessor for MEB and is a member of the EMA QWP. Diana has been rapporteur for many guidelines, including ICH M7 and the Paed GL. She is currently representing the QWP in the PDCO Formulation Working Group and the Steering Committee of The Certification Procedure and rapporteur for the reflection paper on medicines for older people