IMDRF 2023

Qualified to a master’s degree in biotechnology, based in Geneva-Lausanne area in Switzerland and working as a Vice President Regulatory Affairs EMEACLA (Europe, Middle East, Africa, Latin America, and Canada). In my current role I am directing and influencing regulatory strategies and guide the company through multiple regulatory changes and dynamics, including investment into capabilities. I also have a special focus on regulatory and clinical pathways for marketing authorization and patient access, that also includes the risk benefit approach in clinical evidence and Real World Evidence especially for therapies that address unmet medical needs.
Prior to joining Edwards I was a Sr. Director Regulatory Affairs EMEA at Medtronic, headed up Regulatory Affairs at Colgate-Palmolive Europe Sarl. in Basel, Switzerland. I have previously held the management positions in Research and Development, Manufacturing Process Management and Quality Assurance at Unilever company. And have also worked as an independent consultant to the cosmetic industry and for alternative toxicological
methods.