Until now, combination products are more often handled inconsistently in different jurisdictions as drugs and/or devices. The determination as to which regulations, submission procedure and pathway to market is followed for the product is largely based on the its Primary Mode of Action, a new concept in itself.
Ahead of the Combination Products Forum 2018, we spoke exclusively to Viky Verna, Co-Founder and Vice President at confinis, in order to discuss the biggest challenges relating to the combination product regulatory landscape, the best compliance management approaches, and the industry’s outlook and direction towards regulation harmonisation.
The global drug device combination product market is expected to reach USD 177.7 billion by 2024. With input from Medical Device Manufacturers, Pharmaceuticals, Consultants and Solution Providers, this report will explore the key drivers and challenges faced in the drug-device combination products market.
Ensuring that combination products are effectively managed throughout their development, implementation, launch and post-launch is critical to long term success in the market. However, there is arguably still considerable room for improvement throughout this process, and in order to facilitate efficiency all parties must be fully aligned throughout the product lifecycle.
In order to explore this topic in more detail, Pharma IQ spoke exclusively to Dr. Tina Rees, Associate Director-Human Factors, Ferring International Pharmascience Center to discuss product lifecycle management and the areas where simple process improvements could make a significant difference to the overall success of a combination product.