In this foundational workshop, participants will be exposed to challenges, expectations and successful practices for management of combination products throughout the total product lifecycle. Participants will be able to:
- Understand the intricacies of the US and EU approaches to combination products.
- Successfully develop combination products by understanding the similarities, differences, and areas of overlap from the key aspects of drug development and device development requirements.
- Establish a framework to determine what types of post-market changes require what type of regulatory approval.
- Successfully navigate Post-Market Safety reporting expectations through an understanding of challenges and best practices from across the industry.