Nada Hanafi, Experien Group: “Critical Success Factors for Regulatory Strategy”
Set yourself up for success in your startup's approach to effectively navigate the regulatory pathway to market and maximize your interactions with FDA. Join this seminar to hear from Nada Hanafi, Chief Strategy Officer of Experien Group, headquartered in San Jose, CA. This discussion will focus on the critical success factors that go into a comprehensive regulatory strategy and the benefits of FDA’s Q-Submission process for state-of-the-art medical devices and innovative technologies.
Where & When
Room 212, Byers Hall, UCSF Mission Bay (1700 4th St., San Francisco)
5:30 to 6:30 PM, Tuesday, April 23, 2019
About the Speaker
As Chief Strategy Officer at Experien Group, Nada combines her institutional knowledge with innovative approaches to help companies develop actionable premarket strategies to guide programs through successful submission. Nada joined Experien in 2017 after dedicating 12 years at FDA’s Center for Devices and Radiological Health (CDRH). At CDRH, Nada led cross-Center and Agency programs for the advancement of FDA’s mission, including the Health of Women program, the Network of Experts program and the Patient Preference Initiative. She was the CDRH Liaison and Subject Matter Expert to FDA’s Office of Women’s Health and the Office of Minority Health. Nada holds an MS in Biomaterials, a BEng in Biomedical Materials Science & Engineering from Queen Mary College, University of London, and her MPH from Johns Hopkins Bloomberg School of Public Health.