In this webinar we will take you on a journey through the last 30 years in the pharmaceutical industry as the inventor of spray systems for preservative-free applications. We will discuss the benefits of preservative-free formulations in pharmaceuticals, medical devices and cosmetics. We also want to share our insights into the regulatory requirements that pave the way to market and are key to successful product development.
Using the example of a specific aspect of the regulatory landscape in the EU, Regulation (EU) 2017/745 on medical devices, better known as MDR, we will focus on drug-device combinations. These products contain a drug and a medical device and require a rigorous regulatory review, with a focus on defining the principal mode of action. Shedding light on some of these definitions and outlining our approach during the development phase will help you understand our individual portfolio, development and RA service offerings.
Dr. Marie-Christine Klein and Dominik Rocchi offer insights on the complexities of new medical device projects, particularly under the Medical Device Regulation (MDR) and in developing preservative-free sprays. Dr. Klein, as Head of Development and Regulatory Affairs, emphasizes the critical attention needed from development to launch. Rocchi discusses the unique challenges in project planning and supply chain management for these products and the importance of transparency. He also addresses the common issues faced by newcomers to preservative-free product development, drawing on his role as a liaison between URSATEC’s customers and internal departments.
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