Stanford Mussalem Center for Biodesign
Palo Alto, CA
Wilson Sonsini partner Eva Yin is moderating "Navigating Shifts in Regulatory Approval for Pediatric Innovations" at the Impact1 4th CEO Summit, hosted by the Stanford Mussallem Center for Biodesign. Eva is joined by Kim Pretzer of the FDA and Nada Hanafi of MedTech Strategy Advisors.
The two-day summit brings together leading pediatric and maternal health innovators, investors, and key experts for panels, pitch competitions, and candid discussions on the biggest challenges in advancing pediatric and maternal healthcare. Speakers include Mike Mussallem, co-founder of the Mussallem Foundation and former CEO of Edwards Lifesciences; Dr. Michelle Tarver, Director of the FDA's Center for Devices and Radiological Health; and Alex Smith, former quarterback for the San Francisco 49ers. Wilson Sonsini is proud to sponsor the event.
Kaethe Carl
kcarl@wsgr.com
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.