A biomedical engineer by training, Mr. Perfler has 15 years of professional experience specializing in medical device technology and has overseen the development and regulatory approval of over a hundred medical devices. He is a contract professor of “Regulatory Affairs” at University of Pavia, Faculty of Engineering. In 2013, he founded Atricath S.p.A., an innovative startup company focused on the development of atrial fibrillation catheter-based solutions, and raised seeding investment from private investors and VC companies. Mr. Perfler is an active contributor to the ISO technical committee for the biological evaluation of medical devices.
A pharmaceutical & biotechnology graduate with international contracting and business development experience. Mr. Loffredi has written and negotiated public and private tenders for phase I – IV clinical research studies encompassing a wide range of indications, with a focus in wound healing, cardiovascular and anti-infectives. Mr. Loffredi received a B.S in Pharmaceutical & Chemical Science from the University of Brighton and an M.S in Biotechnology from Georgetown University.
Trained as a biomedical engineer, Mr. Malaspina has developed and brought to market wound management products, aesthetic-reconstructive surgery and orthopedics implants. He regularly dialogues with foreign competent authorities and authorized representatives for product certification in Europe, Middle and Far East, North Africa, South America, USA, Australia and Japan. Mr. Malaspina holds a B.A and M.S in Biomedical Engineering from the University of Pavia.
Ms. Fosforani regularly evaluates product feasibility and classification, advises on regulatory strategy and prepares technical and drug master files for class III and combination products with topical applications indicated for gynecology, wound management, ophthalmology and women’s health. Her background includes experience as a quality assurance specialist with a focus on obtaining CE marking approval. Ms. Fosforani holds a B.A in Biotechnology and an M.S in Medical and Pharmaceutical Biotechnology from the University of Pavia.
An expert in European medical device regulations for clinical data and clinical trials, Mr. Oliveri has supported the development of a wide array of devices, including dental and cardiovascular implants, in-vitro diagnostics, and specialized wound management systems. He is a 13485 certified lead auditor and regularly supports clients in developing and implementing quality management systems. He is also expert in product CE marking for class IIa, IIb and III medical devices and conducts risk analysis in conformity with ISO 14971. Mr. Oliveri received a B.A. in Biomedical Engineering from the University of Genova.
Mr. Paglianiti has extensive experience in regulatory activities connected with class I to III medical devices, IVD and food supplements. He regularly engages notified bodies and regulators about product classification and manages the preparation and submission of technical files for EU countries, North and South America, Australia, Russia, Far East and Middle East. Mr. Paglianiti received an M.S. in Chemistry and Pharmaceutical Technologies from the University of Calabria.
Ms. Daniela Rotaru, has over 20 years of experience in the pharmaceutical industry with considerable expertise in: clinical trials management and operations, marketing, sales, and medical writing. She has supported activities such as pharmacovigilance, auditing, medical and regulatory affairs; organizing investigator’s meeting, steering committees and safety boards. Ms. Rotaru has managed and coordinated across functional international and national project teams for all phases of clinical trials in several therapeutic areas, such as but not limited to: Cardiology, Oncology, CNS, Rheumatology, GE, Pediatrics, Diabetes, HIV/AIDS, Orthopedics and Oral care. Her clinical and management qualifications combined with strong communication skills enable her to facilitate interaction with key opinion leaders, protocol preparation, site selection and difficult to recruit populations.
With over 20 years of experience, having managed over 40 clinical trials in oncology, cardiology, virology, CNS, rheumatology, immunology, hematology, women’s health and anesthesiology, Dr. Cattaneo is considered the team’s project management expert. His tenure at a global CRO and expertise in multicenter trials ensures that trials remain within forecasted timelines whilst respecting regulations, quality, and costs. He has experience supervising and supporting startup activities including site selection, as well as organizing and coordinating meetings and steering committees. Dr. Cattaneo holds a Ph.D. in Animal Biology with a focus in Cytochemistry and Histochemistry from the University of Pavia.
Having previously coordinated operational activities for a local engineering society, Ms. Beretta was first introduced to clinical research in a supportive role to the quality management division of an international CRO. She has monitored multi-centered clinical trials with immunology, rheumatology, dermatology and ophthalmology indications, for major pharmaceutical companies. Ms. Beretta received a B.S in Biotechnologies and an M.S in Medical Biotechnologies from the University of Milano Bicocca with an experimental thesis on nano-sized drug delivery systems
Ms. Gorla supports senior regulatory staff in writing clinical report evaluation, risk analysis and technical master files for medical devices. She received a B.A and an M.S in Biomedical Engineering from the Polytechnic University of Milan, with a specialization in biomechanics and biomaterials. Ms. Gorla co-authored a publication on her master thesis focusing on platelet activation in therapeutic blood recirculating devices.
Prior to joining 1MED Ms. Distefano gained experience in the clinical field by planning, coordinating and building patient rapport in phase II and III immunotherapeutic oncology trials. Her experience and direct contact with end users enables her to provide a real world perspective in the clinical evaluation of medical devices and combination products. She received a B.A in Biotechnology and an M.S in Medical and Pharmaceutical Biotechnology from the University of Pavia.