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. He is part of PDA Chapter Italy - Board of Directors since 2014 and has served the chapter in a number of elected capacities including Secretary and Quality Subject Matter Expert. He will act as Regulatory Watch and Inspections Trends Leader in the current 2024-25 mandate. Michele has been serving on PDA’s RAQAB since 2022, setting strategic direction for the PDA on topics associated with regulatory affairs and quality, contributing to the board’s regulatory commenting. 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 Artificial Intelligence (AI) and Knowledge Management (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. Michele sits on the Program Committee for the 2024 PDA Annual Meeting, and is an Abstract Reviewer for the Annual Meeting’s Science Track Sub-Committee. Michele has presented, chaired and moderated several PDA events including the PDA Annex 1 Workshop (Italy), PDA Annual 2023, PDA Europe Quality and Regulatory Conference 2018-2019 and 2023.