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.

Theresa is a RA/QA Sr. Principal Advisor at Fortrea Inc. with 30 years in medical device and pharmaceuticals, supporting roles in IVD R&D, pharmaceutical clinical and RA, and in medical device RA/QA for the past 18 years. Theresa works with clients to develop global regulatory strategies and submissions for medical devices and combination products throughout the product life cycle. She has worked on medical devices in the areas of cardiovascular, ENT, gastroenterology/urology, orthopedics, neurology, and clinical chemistry; and in pharmaceutical/biologic programs to support indications in dermatology, hematology, infectious disease, neurology, oncology, and reproductive/urology. Theresa obtained a BS in Biochemistry and maintains her RAC.

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).

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.

Jenifer Hannon is the Post Market Surveillance Regulatory Lead for medical devices at BSI. Jenifer is passionate about the role and the use of post market data and experience to deliver safe and effective medical devices for patients, whilst recognising the role it can play in supporting innovation. In addition to her role at the Notified Body, Jenifer’s experience includes 14 years working for a UK-based medical device manufacturer and over 8 years working for the UK competent authority, MHRA, where she led teams responsible for surveillance activities including evaluating the safety and performance of medical devices and medicines.

Elisabeth has a background in International Business and Biomedical Engineering. She has over ten years’ experience in the medical device industry and clinical evaluations. During her work as Product Manager and Head of Professional Education in Germany and the United Kingdom she was always heavily involved in clinical evaluations and clinical studies before deciding to solely focus on this area. Elisabeth started working as a freelancer in 2019 and finally founded Escentia GmbH in 2021. Her focus is on simplifying processes and keeping clinical evaluations easy to read and understand.

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.

Sheila holds an Honours Degree in Biomedical Engineering from the University of Ulster. Sheila started her career in the Medical Device Industry focusing on the manufacture of Cardiovascular devices. After this, she moved into a Clinical Research based role, where she was responsible for the conduct of Clinical Studies. Sheila joined BSI in 2007 and has over 16 years Notified Body experience, as a Scheme Manager, Technical Specialist, Clinical Evaluation Specialist and Decision Maker. Sheila has comprehensive knowledge of the MDD and MDR with a particular interest in the clinical aspects of Conformity Assessment. Since 2022 she is responsible for providing clinical regulatory support to the BSI teams.

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.