Michele Simone Bracco

Michele Simone is a Biologist and Clinical Pathologist by education. "Qualified Person" according to Directive 2001/83/EC. He is currently acting as Director of Corporate Quality Risk Management & Continual Improvement for the Bracco Group, an international group active in the healthcare sector, and a global leader in diagnostic imaging. Michele has + 30 years’ experience in the pharma/biopharma industry, and he hold different sites and corporate Quality roles in different organization, including but not limited to Serono, Janssen Cilag, J&J, Novartis V&D and Merck. Michele is an active member of PDA since 2004. Michele served on the Program Committee for the 2024 PDA Annual Meeting and chaired/presented at many PDA events/conferences. He is part of PDA Chapter Italy - Board of Directors since 2014. Michele has been serving on PDA’s RAQAB since 2022. Michele is the Lead of the PDA IG “Quality System”. Michele is part of the PDA Task Force “Knowledge Management” and he serves as Sub Team Leader for AI and KM. Michele was part of the PDA Task Force “Remote Audits and Inspections” and he contributed to issue the PDA Point of Consider – Remote Audits and to review the PDA Point of Consider – Remote Inspections.