Brad Nelson Dr. Ulla Grauschopf

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1 Plenary Session Brad Nelson is the Professor of Robotics and Intelligent Systems at ETH Zürich. His primary research focus is on microrobotics and nanorobotics emphasizing applications in biology and medicine. He received a B.S.M.E. from the University of Illinois and an M.S.M.E. from the University of Minnesota. He has been at Honeywell and Motorola and served as a United States Peace Corps Volunteer in Botswana, Africa, before obtaining a Ph.D. in Robotics from Carnegie Mellon University in He was Assistant Professor at the University of Illinois at Chicago ( ) and Associate Professor at the University of Minnesota ( ). He became Full Professor at ETH Zürich in He has received a number of awards and serves on several editorial boards. He has been Department Head of Mechanical and Process Engineering, Chairman of the ETH Electron Microscopy Center, and a member of the Research Council of the Swiss National Science Foundation. Dr. Ulla Grauschopf was appointed Head of Device Development at Hoffmann-La Roche in Basel mid of She is a biochemist by training with a strong focus on biophysical characterization of protein molecules and joined Roche after some years in academic research. Ulla's background spans more than 11 years of technical R&D experience in all fields of drug product development, including formulation, analytics, drug product process, manufacturing & transfer, primary packaging and device, and regulatory strategies.

2 Plenary session Dr. Bassil Akra is the vice president of the global focus teams (Cardiovascular, Orthopedic and Clinical) at TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra is leading various consultation processes of medical devices incorporating an ancillary medicinal sub- stance with the different competent authorities designated by the Member States or the EMA. As a senior field expert, he is presenting worldwide the requirements in Europe and is involved in the development of several European guidance documents and standards. He is member of the European Clinical Investigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other Guidance Documents on Innovative Devices. Dr. Akra is member of the German MDR Implementation Working Group, the NAKI. He is also member of the European task force on Safety Update Reporting.

3 Workshop 1 Priscilla Brunetto was born in New Caledonia. She obtained her Bachelor and Master degree in Biochemistry from the University Claude Bernard Lyon 1, France in 2004 and received her Ph.D. degree in Chemistry from the University of Fribourg, Switzerland in 2010 under the direction of Professor Dr. Katharina M. Fromm. Her Ph.D. research was focused on the development of new antimicrobial surfaces for implants and medical devices application. From 2010 to 2015, she continued her work on antimicrobial surfaces as project leader for CTI projects at the University of Fribourg, Switzerland. Since 2015, she works as a Maître- Assistante at the University of Fribourg, Switzerland in the group of Prof. Dr. Katharina M. Fromm Vanya Loroch is a life science educator, writer and advisor with a broad expert knowledge in biology, biotechnology, medical information management, health promotion and prevention, sports doping and anti-doping. Leveraging on his twenty year experience in innovative educational projects, Dr. Loroch has developed a highly effective method for introductory and continuing education aimed at all professionals, that need to gain a sound understanding of life sciences. He is the Education Director of the SBA Academy and Professor at the Lausanne Business School where he teaches Biology for Sustainable Business, a unique course that links life sciences to sustainability for the benefit of future business leaders.

4 Workshop 2 Christa Spitznagel studierte Pharmazie an der ETH in Zürich. Sie verfügt über langjährige Pharma- Industrieerfahrung mit Kernkompetenzen im Bereich Regulatory Affairs, Health Care Compliance, Pharmacovigilance und Medical Information. Für Allergan arbeitete sie seit 6 Jahren als Leiterin der Regulatory Affairs Abteilung, zuständig für die Schweiz und Österreich. Auf Grund des breiten Portfolios an Arzneimitteln und verschiedener Kategorien von Medizinprodukten der Klassen II und III kennt sie sich mit klinischen Daten und deren Aufarbeitung und Erstellung zur Erlangung der Zulassung sehr gut aus. Sie ist Mitglied verschiedener beruflicher Gremien: Vorstandsmitglied der MEGRA und Leitung der MEGRA-Fachgruppe Pharmacovigilance; Mitglied der Arbeitsgruppe Datenpolitik von Scienceindustries. Ivo Schauwecker holds a degree in biochemistry and a diploma in Pharmaceutical Medicine (EUCOR/ECPM). He has over 20 years of operational experience in international clinical research in the pharmaceutical, medical device and CRO industry. He started his career in clinical research with the CRO Pharma Focus Consultants (now Clinipace) in Switzerland. After that he became co-founder of the CRO Appletree in Switzerland and was serving the company for 6 years. He joined the clinical research institute AOCID of the AO Foundation 7 years ago. At the AOCID he is member of the managing team and is responsible for various fields of activities. His responsibilities are client relations and business development as well as vendor management. He is supporting the development of the educational activities and acts as faculty in various international courses offered by AOCID. He also serves as board member of the Swiss Association of Pharmaceutical Professionals (SwAPP) for more than 14 years.

5 Workshop 3 Kathrin Abegg studied Veterinary Medicine with a focus on Biomedical Research at the University Zürich. She completed a PhD thesis in the field of obesity and diabetes research and a postdoc for the evaluation of a potential novel treatment option for diabetes mellitus. The results of both research projects were published in the peer-reviewed literature. After leaving academic research, she was involved in the approval of animal experiments at the Veterinary Office of the Canton of Zürich for a year before starting as Clinical and Regulatory Affairs Manager with ISS AG in Her focus at ISS AG lies with the preparation of clinical evaluation reports and with the implementation of changes brought about by the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) with regard to clinical evaluations and performance evaluations of IVDs. Rainer Voelksen started his career in regulatory affairs (RA) with a French veterinarian pharma company then with two major osteosynthesis/joint prosthesis manufacturers in Switzerland. For two years Rainer was the director of RA Europe for US biotech company Genzyme, the Netherlands. In 1998, he joined the Swiss Government regulator for medical devices (MD), which became Swissmedic later on. In 2005, he joined the Australian Therapeutic Goods Administration (TGA) for a one-year delegation from Swissmedic. After that year, he built up the Asia Pacific regulatory network for Synthes, being based in Australia. Back in Europe, he joined GE Healthcare in Paris as the executive for regulatory and quality affairs, later Edwards Lifesciences as VP of international RA. After some years at Swiss Federal Office of Public Health to implement the new EU MD and IVD regulations into Swiss law, followed by two years at a Swiss cardio-vascular group (as VP RA & QM). Recently Rainer moved to become a Senior RA strategy consultant. Being a member of RAPS for more than 20 years, Rainer served as chairman of RAPS board of directors. He was awarded the RAPS Fellow distinction in September of He serves as the cochair of the European advisory committee of RAPS.