Combination Products: Considerations for Entering a New Market ( WEBCOMBPROD )
What does it take for pharmaceutical, medical device, and biologics companies to enter the market of Combination Products (CP)? The overlapping elements of traditional pharmaceutical product development stage gates and medical device product development prescribed by design controls create challenges for development scientists, quality, regulatory, and operations professionals in the development of a CP. Using case studies and real-world problem solving techniques, you can learn from the successes and failures of those that have already undergone this process. A representative from the Office of Combination Products will give a presentation from the U.S. FDA’s perspective to give this topic added depth and dimension. The session will conclude with a panel Q&A where participants are encouraged to engage the speakers in lively discussion. Don’t miss out on this exciting session!
At the conclusion of this session, participants will be able to: