Senior Director, Global Regulatory Affairs, Device and Combination Products Sanofi
A device supplier and a pharmaceutical company will present a combined use drug-device case study to illustrate the two sides of global regulatory challenges and how to navigate through these challenges in a development partnership. A panel discussion among industry representatives will follow; they will exchange thoughts concerning similar challenges pertaining to relationships with supplier-owned medical devices that are not co-developed. The intent is to build awareness of anticipated challenges and risks related to industry partnerships, so they can plan accordingly. Topics during this session will include identifying R&R, sharing of documents/DHF and other sensitive information, collaborating on submissions (and submission strategies), identifying/navigating global regulatory pathways, plus legal manufacturer considerations and labeling development.
