Dr Roberto De Lisa, Clinical Pharmacologist, joined the EMA in 2006. Since then he held various positions in Medical Information and Pharmacovigilance working for the CHMP Pharmacovigilance Working Party (PhVWP) and the Pharmacovigilance Assessment Committee (PRAC). As of 2015 he joined the Paediatric Office working as Paediatric Coordinator with a special interest in paediatric pharmacovigilance. Prior to joining the EMA, Dr De Lisa worked for the University Hospital San Giovanni di Dio in Cagliari for 5 years, conducting clinical trials and participating in the activities of the local Ethic Committee and in the creation of the Pharmacovigilance Centre. He obtained a Master Degree in PharmacoEconomics from the University of Milan in 2005.

Mette is Managing Director of "PIP Adviser" which provides expert regulatory advice on PIPs and PSPs. She has a background in authorities & industry. In the Danish Medicines Agency (2000-2006), she was nonclinical assessor of MAAs and EU Scientific Advice. She was member of the SWP, Gene Therapy WP, Biosimilar WP and PGWP and a rapporteur for CHMP and ICH guidelines. As Scientific Officer in EMA, Mette handled PIP procedures with PDCO, was in the FDA-EMA paediatric cluster and established the PDCO Nonclinical Expert Group. In Novo Nordisk (2009-2017), Mette lead all PIP/PSP procedures, was paediatric strategy advisor across the company and was in the EFPIA paed group. Mette also spent a year as Senior Director in Shionogi, London.