FDANEWS presents the Combination Products Regulation, Policy, and Best Practices first ever all-day conference on June 8 in Washington, DC. The conference features 17 experts from every background — drugs, devices, biologics, generics, regulatory, legal, consulting, and more. You’ll be able to:
- Adopt three successful tactics and strategies for obtaining jurisdictional determination, assuring certainty with submission requirements, and overcoming barriers to combination product approval
- Understand postmarket safety reporting and current good manufacturing practices requirements for combination product and constituent part sponsors to better enable you to stay in compliance with agency mandates
- Comply with the unique considerations for advertising and marketing your combination products
- Know the three critical findings of a human factors study of a generic combination product with device delivery constituent part
- Implement three best practices for submitting combination products directly to CDRH and understand three important implications of the Cures Act on these submissions
Suzanne O'Shea, director at Navigant, will participate on the panel "Combination Products Determination and Review Processes: Impact of 21st Century Cures Act and Recent FDA Initiatives" at 9:45 a.m.