Whether you are thinking/about to launch a MedTech startup (incl. diagnostics, software etc.) or already in business, it is always challenging to navigate the regulations.
Nevertheless, it is crucial to be well prepared and guided in order to make informed decisions: develop the right product for the right market, define a relevant registration pathway and design a realistic business plan to convince investors while being able to execute your strategy.
What is the new EU regulatory framework ? What are the key items impacting a business plan ? How to establish a realistic registration strategy ? What about pharmaceutical products having a medical device component ?
This workshop is aimed at discussing the applicable regulation and its challenges, as well as sharing expert/practical advices on various concerns you may have on the development of medical devices.
Speaker: Marie Gaumet, PharmD, PhD – ISS AG, Integrated Scientific Services
About the speaker:
Marie Gaumet is Pharmacist by training and holds a Master in Biological and Medical Sciences (France). She obtained her PhD in Pharmaceutical Sciences from the University of Geneva (Switzerland) in 2007. Thanks to the Swiss National Fund, she was then Post-Doctoral Fellow at the University of Minnesota (US).
Marie started an industrial career at TRB Chemedical International (Geneva, Switzerland) where she had increasing responsibilities and different roles, from Clinical Research Scientist to Clinical and Medical Affairs Officer. She was in charge of managing R&D studies from ideation to clinical steps, while providing scientific support to other departments such as Regulatory, Marketing and Business Development, within TRB and its international affiliate. Therefore, Marie gained a strategic overview of drug and medtech products development.
Marie is now Responsible for the Western Switzerland Office of ISS AG, Integrated Scientific Services, a company based in BieI/Bienne (Switzerland) providing strategic and operational expertise in the development of medical devices, from introduction into the market to maintenance. Marie joined ISS AG in 2018 as Business Development and Project Manager to accompany Medtech companies from their needs identification to the jointly defined goals achievement. She ensures the delivery of expertise in Regulatory & Clinical Affairs, Quality Management, Engineering Support and Software Development.
Besides, Marie is member of the Board of Directors of SwAPP (Swiss Association of Pharmaceutical Professionals), a professional association for qualified specialists working in Pharmaceutical Medicine and Drug Development.
More info on ISS: https://www.iss-ag.ch/en
Apr 9, 2021