Combination products are a hot topic in healthcare. While these products open doors to exciting new possibilities, they also bring new challenges. This session discusses the importance of promoting a culture of compliance to build a compliant lifecycle management infrastructure around combination products to ensure appropriate cGXPs and Quality System regulations are enforced throughout the franchise.
Global Regulatory Changes and Emerging Markets
The global landscape for combination products is constantly changing. New regulations and policies are emerging within key international markets and it is essential that companies understand expectations to ensure successful marketing and change management strategies. This session covers the EU Medical Device Regulation and its impact on combination products as well as an overview of international combination product regulation within emerging markets.