Effectively engaging with the FDA is a critical step for any innovator to bring a life-science product to market. Led by Laura Rose, PhD, this session will demystify the FDA, help you map your regulatory path to market, and explore partnerships with Contract Research Organizations (CROs).
Topics include:
- Decision framework for engaging the FDA
- FDA’s structure and how to determine the correct office for your product
- Regulatory-ready basics of product development
- How to identify and work with CROs and the role of CMC
- Best practices for balancing publicizing research with regulatory approval requirements
Speaker:
Laura Rose, PhD, is a biomedical engineer with deep expertise in FDA regulatory pathways for medical devices and combination products. Before joining Bruder Consulting Venture Group, she spent nearly eight years at FDA, most recently as Assistant Director in CDRH’s Office of Orthopedic Devices, where she led multidisciplinary teams and collaborated extensively with CBER and CDER. Laura brings a practical, strategic approach to regulatory problem-solving and has a strong background in tissue engineering, regenerative medicine, and cell therapy.
OFFICE HOURS: Laura has offered to host 20-minute in person office hours following the seminar for individuals who have specific questions or would like to dig a little deeper. These are offered on a first come, first serve basis and must be scheduled in advance. Please email Alex Voss at [email protected], if you are interested in scheduling office hours.