Often, US Food & Drug Administration (FDA) Advisory Panel meetings are the capstone to what is characteristically a long and arduous medical device development journey. While these meetings typically close with a voting session on a medical device’s approvability, recent real-world experiences demonstrate that achieving a favorable set of panel votes does not always guarantee swift FDA approval of the medical device under consideration.
To better understand how to effectively prepare and plan for successful Advisory Panel meetings, NAMSA will present a webinar on strategies for working with the FDA for medical device manufacturers.
Join Chris Mullin, Director of Product Development Strategy (NAMSA), as he provides information on strategies that lead to success, including:
- Discussing and evaluating the role of FDA Advisory Panel meetings and how they contribute to the FDA’s decision-making
- Understanding three key aspects of Advisory Panel meeting preparation:
- Planning the appropriate clinical strategy
- Executing successfully on the set strategy
- Anticipating issues and concerns throughout the process
- Examining how to improve chances of FDA approval, including post-meeting initiatives
- Understanding how Advisory Panel meeting takeaways can be used more broadly throughout the medical device continuum
Chris Mullin, Director of Product Development Strategy, NAMSA
Chris Mullin, is currently the Director of Product Development Strategy at NAMSA where he consults with clients to bring their medical devices to market. He holds a BS in mathematics from the University of Wisconsin and an MS from the School of Public Health at the University of Minnesota.
Chris started his career working on NIH funded clinical trials and over the past ten years has been consulting for medical device companies, helping to design and analyze their clinical research and navigate regulatory requirements for market approval. He’s served as a university instructor, an author of several peer-reviewed publications, acts as a journal editor, and has authored a forthcoming book chapter on clinical study design for translational research. Working with novel technologies across a wide array of therapeutic areas, and with manufacturers both large and small, has given him valuable perspectives on the scientific and regulatory challenges device companies face in advancing medical technology.Message Presenter
Who Should Attend?
Department Heads/Senior Professionals working within:
- Regulatory Affairs
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines — consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality — to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.