Street: Movenpcik Hotel, Zurich Airport
This one day conference will provide delegates with an understanding of the regulatory framework and highlight the challenges of developing combination products. It will focus on the differences between device and pharma regulations and will provide examples of issues faced by manufacturers already operating on the medical product/medical device borderline, designing products where the regulatory framework is not immediatly obvious.
Objectives:
•To give delegates a clearer understanding of the regulatory options and routes that are available to manufacturers developing different kinds of medicinal and medical device combination products.
•To provide an open forum to discuss the relative merits and drawbacks between the two regulatory frameworks, particularly in situations where there are multiple options
Key Topics:
•Overview of Regulatory Framework in the EU and US for Combination Products
•Challenges in developing combination products
•Competent Authority and Notified Body views and their roles in regulating combination products
•Strategic moves affecting drug and device regulations at the European Commission level
•Case studies
Who will attend:
•Pharma and medical device industry professionals
•Health authority experts
•Notified body representatives
•Regulatory, clinical and other professionals responsible for developing combination products
For more information on the event, please click here