Manage episode 377906552 series 3428201
How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of harmonizing drug and device elements, managing risks, and understanding variability can be overwhelming. If clinical readiness is on your product development plan, join our discussion with Dr. Stefanie Johns, Director of Regulatory Affairs at Kymanox, as she shares her strategies to solve the clinical readiness puzzle.
Shannon Hoste, Vice President of Agilis by Kymanox and Stefanie delve into factors like patient safety, human factors engineering, and the challenges faced by pharmaceutical companies entering the device realm. They emphasize the importance of understanding the interplay between the device and drug, highlighting that any source of variability can be amplified in clinical trials. Additionally, they discuss how best to utilize a risk based approach in determining strategy and to ensure product success and regulatory compliance. A must-listen for those in the medical device and pharmaceutical industries.
About The Factor:
To err is human. That’s where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user. It is brought to you by Agilis by Kymanox, and is produced by Earfluence.