The webinar series MDR@noon offers all interested parties an insight into the relevant regulatory issues for the medical device industry. The entire event will be held in English and is free of charge. It starts at noon and finishes at 13.00 h.
The role of industry in shaping the regulatory environment for combined products
Experts will discuss the latest developments in European and Swiss regulations for combined products and the opportunities and challenges the healthcare industry faces. Combined products refer to an increasing range of products that include drugs and device combination products being classified as drug or device as well as combined use of software as medical device and companion diagnostics with drugs to fulfil a medical purpose. Industry associations can make an important contribution to ensuring that the regulatory framework guarantees both patient safety and appropriate access to innovation.
Participants will also have the opportunity to provide their perspectives, and have their questions answered on combined products, the associations and upcoming events.
Program
12.00 – 12.05 h: Welcome - moderated by Dr. Daniel Delfosse
12.05 – 12.15 h: The Medtech & Pharma Platform Association (MPP). What are combined products? - Speaker: Shayesteh Fürst-Ladani (President MPP)
12.15 – 12.25 h: EU regulations on drug/device combination products - Speaker: Karl Mayerhofer (Ypsomed AG)
12.25 – 12.35 h: Swiss regulations on medical devices - latest developments - Speaker: Daniel Delfosse (Swiss Medtech)
12.35 – 12.45 h: MPP activities to shape the regulatory environment for combined products - Speaker: Thomas Kühler (Sanofi-Aventis)
12.45 – 13.00 h: Q&A session
