Anna Bottura, qualified as Medical engineer is working as business development manager in Arithmos. She is the medical device specialist of the Company. Anna has about 6 years of experience in medical device regulation and quality system. During the last year she had working in projects for the transition plan from MDD to MDR of high risk medical devices. Anna has a good knowledge in Risk Evaluation Assessment, Post Market Surveillance system and Clinical Evaluation requirements.
Graduated in Chemistry and Pharmaceutical Technologies at the University of Genoa, she has more than twenty years of experience in the field of CROs. She has worked as Project Manager for numerous clinical projects for the most important pharmaceutical companies and for Health Institutions. After having held the role of Clinical Operation Manager at a CRO for some years, Laura is now the Scientific Director of Latis Srl and of Elle Research Srl, two CROs that deal with the design and conduct of pre and post-market clinical studies with medical devices, supporting manufacturer in the acquisition of clinical data on their products.
Mr. Arkan Zwick is Corporate Regulatory Affairs Director of a private global pharmaceutical and surgical company with products in ophthalmology, orthopaedic and aesthetic dermatology. With more than eleven years, regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device and cosmetic projects as well as in house legal advice for contract management, merger and acquisition and intellectual property. He is responsible for regulatory compliance in the EU working with different notified bodies and for global market authorizations in the Americas and Asia-Pacific. Arkan has a graduate master degree in Law from the University of Vienna and a PhD in European Law. He has been assigned as lecturer at the University of Applied Sciences in Vienna and as speaker on life cycle conferences and trainings. He is fluent speaker in English, German and French.