I’m a biologist by training. For the past 10+ years I’ve been working on medical device vigilance and clinical safety reporting and supported PMS and other device lifecycle activities. I have worked with medical devices from Class I to Class III and with drug-device combinations. I've been involved in the implementation of multiple regulations for both devices and combination products globally, with particular focus on EU MDR and FDA 21 CFR Part 4, and the setup of high-complexity vigilance systems and processes in a matrix organizations. I'm passionate about education and have been involved in multiple learning initiatives throughout the years.

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.

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.

Ana Simoes is a Consultant ENT Surgeon in Portugal with 19 years of clinical practice, 13 as ENT specialist. In 2022, initiated her pathway in regulatory affairs as Clinical Reviewer working at the Clinical Centre of Excellence at TÜV-SÜD. She is an authorised clinical reviewer for the EU MDR and works with high and low risk class medical devices, assessing clinical benefit-risk ratio and compliance; she acts as Subject Matter Expert for Otolaryngology. Interested in technology, digital health and quality has also training in Health Management and AI in Heath Care. She is a member of the governance bodies of Portuguese Neurotology Association.

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.

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.