Leon Doorn, Expert within the field of AI-enabled medical devices, previously affiliated with Aidence B.V., A RadNet Inc. company. At Aidence, Leon was working as Regulatory Intelligence, supporting the development of AI-enabled Medical Devices. Leon further supports the development of practical regulations and standards within the field of AI-enabled Medical Devices. Within Aidence, he and his team were one of the first organisations within the AI space to gain MDR certification. In addition to his regulatory activities, Leon is active within the standardisation organisations (ISO/IEC, CEN/CENELEC and NEN).

Josep holds a PharmD degree, an MSc in Pharmacology, an MSc in Pharmaceutical Industry and a PhD in Medical Device Safety from the School of Medicine at Erasmus University of Rotterdam (The Netherlands). He has 14 years of global biopharmaceutical and medical device industry experience in pre-market and post-market safety, vigilance and quality, having worked both in Europe and in the US. In his current role, he leads the Global Device and Digital Vigilance & Safety team at UCB. Josep has also worked as guest lecturer at the University of Barcelona and collaborated as peer reviewer with various scientific journals.

Clinical safety professional, engaged with safety oversight of medical devices clinical investigations globally. Responsible for continuous integration of safety information into products' benefit-risk assessment with main focus on implantable devices in the area of orthopaedic reconstruction and repair, and advanced wound care. Member of Serbian Institute for Standardisation technical committee on medical devices, mirror to ISO TC 194, acting as a national lead for ISO 14155 implementation. Pharmacist by training, experienced in topics of regulatory compliance and quality and always keen to meet fellow professionals and join a cross-discipline initiative.

James Whitehead is the Senior Director, Device & Digital Safety at AstraZeneca working within Global Patient Safety, having started his career with AZ as a Pharmacovigilance Scientist in Oncology. Since graduating with a BSc in Psychology from the University of Leicester, James has held positions at CROs, Pharmaceutical Companies and Consulting Practises with a focus on Signal and Risk Management. That passion for Signal and Risk Management culminated in a MSc in Pharmacovigilance from the University of Hertfordshire, James is now a Visiting Lecturer on the course. Recently, James studied for an MBA and focused this project on innovation and digital transformation within Patient Safety.

Sarina Zillikens is a Clinical Affairs Specialist at Escentia GmbH, where she is responsible for Clinical Evaluations in compliance with MDR for a broad spectrum of clients in the medical technology sector. Sarina holds a Bachelor’s degree in Biomedical Engineering and an international Master’s degree in Medical Technology and Healthcare Business, with studies in three countries. This educational background allows her to integrate technological expertise with clinical affairs, driving her passion for enhancing processes through innovative projects, including the application of AI in clinical evaluations.

Anna Amich is deputy EU-QPPV and PRRC officer at Novartis. In 2002, she started her career in pharmacovigilance and medical device vigilance at Alcon. In January 2017, Anna moved to Novartis Chief Medical Office and Patient Safety and in 2018 became the head of Process Excellence. In 2020, she joined the Novartis QPPV office being one of her main responsibilities the oversight of the medical device Post-Market Surveillance and Vigilance system and the safety oversight of Novartis medical devices and medical device constituent part of combination products. Anna holds a Master Science in Clinical Trials monitoring, and a PG certificate in Epidemiology. Anna is also a member of the Team-PRRC organisation.