Mireille Muller is currently Executive Regulatory Policy Director at Novartis, focusing on clinical trials, advanced therapy medicinal products (cell and gene therapies), personalised medicines. She is also supporting efforts towards digitalisation in clinical research. She is involved in several IMI projects (IMI PREFER on patient preference elicitation for decision making by regulators and health technology bodies). Mireille is part of several EFPIA groups such as the Clinical Development Expert Group, expedited pathways (PRIME) and Scientific Advice (part of ERAO) group and is on the Personalised Medicine working group. She is part of the EuropaBio group on advanced therapy medicinal products and Policy. She is also part of several other groups such as IFPMA, eClinical Forum, DIA patient engagement, all related in improving clinical research, patients’ rights and well-being. Mireille is providing training on a regular basis both internally and at university level and chaired several sessions at DIA and other conferences.