Robert is a drug and medical device development professional with focus on safety. He has served as ward physician, field monitor, clinical trial head, research physician, drug safety leader in early and late development, and supported development of digital solutions with medical safety focus. He has experience in developing medicinal products in cardiovascular and respiratory indications (hypertension,heart failure, asthma, COPD etc.) and medical devices - including smart inhalers, patient application, diagnostic softwares, etc. - in different disease areas. He recently focused on medical safety in early development – transition from preclinical to clinical stages – and utilization of Artificial Intelligent in drug / device development.

Taylor is a dedicated quality engineering professional specializing in risk management for medical devices with a decade of experience. Taylor possesses an educational background in Biomedical Engineering from the Milwaukee School of Engineering. His career has seen key positions at notable companies such as Medtronic, Philips Healthcare, and most recently iRhythm Technologies, where Taylor has played a critical role in enhancing risk management processes and regulatory compliance.

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).

Glory Msacky is a medical doctor with over 7 years of experience in clinical research, regulatory compliance, and post-market surveillance. She focuses on drug delivery and digital health, supporting connected medical devices with SiMD and SaMD. Her work leverages real-world data and risk-based strategies to advance global product development and lifecycle management.

Harminder has an MSci in Chemistry from Imperial College and has worked in the pharmaceutical industry for 20 years. He has 14 years of experience within Patient Safety, primarily working in pharmacovigilance. He joined AstraZeneca in 2018 and took a role in the Device & Digital Safety team in 2021. Since joining the team, he has gained a range of experience in combination products, medical devices, in-vitro diagnostics and digital health. He is currently the process lead for Post Market Surveillance and Vigilance for combination products and medical devices.

Ortzi Olasolo is a regulatory expert with extensive experience in product development and validation for drug-device combination products and medical devices. Based in Basel, Switzerland, he has provided regulatory support to major industry players as part of Beyond Conception GmbH, including Bayer, Novartis, and Sandoz. Ortzi excels in global submissions, agency interactions, and authoring dossiers, with a strong grasp of Quality Management Systems, Design Controls, Clinical Evaluations, and Risk Management. Skilled in MDR 2017/745, FDA QSR, and ISO 13485, he delivers impactful regulatory strategies and solutions.

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.

Safety professional, engaged with establishment and monitoring of processes relating to medical devices vigilance and clinical safety oversight. Pharmacist by training with experience in regulatory compliance and quality principles related to devices good clinical practice, vigilance/post market surveillance and late development of medical devices. Member of Serbian Institute for Standardisation technical committee on medical devices, mirror to ISO TC 194, acting as a national lead for ISO 14155 GCP and development of ISO 18969 on clinical evaluation. Chair of MedTech and Pharma Platform working group on PostMarket Surveillance and Vigilance.

Dr. Surash Surash is a Clinical Reviewer working at the Centre for Clinical Excellence at TÜV-SÜD. He was a Consultant Neurosurgeon in the UK before transitioning into the world of medical device regulatory affairs. Dr Surash also has a law degree (LLM) and has litigation experience in clinical negligence. Dr Surash is an authorised clinical reviewer in both the EU MDR and UK, and is the clinical subject matter expert for orphan medical devices and In Silico methodologies at TÜV-SÜD. He is also a member of the EU COMBINE, Virtual Human Twin projects and the Avicenna Alliance standards and NB task force.

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 a Director of Device and Digital Safety at AstraZeneca, where she oversees the Clinical Evaluation and Investigation process for medical devices. With a MSc in Clinical Trials Monitoring, and a PG Certificate in Epidemiology, Anna brings over 20 years of extensive experience in ensuring the safety of pharmaceutical and medical device products, both pre- and post-market introduction. Before her current role, Anna held key roles at Novartis, she served as the EU QPPV deputy and PRRC officer. Prior to her time at Novartis, Anna contributed to the Patient Safety department at Alcon Laboratories. Anna is a member of the Team-PRRC organization and serves as a designated expert by UNE.