Short Course: October 7
Meeting: October 13-14

Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management. Properly conceived, risk management offers a holistic framework and process to identify and address the full sweep of considerations for development, efficacy, as well as safety investigation, manufacturing, and the safety and efficacy of post-marketing changes. However, risk managment may be complicated by the challenges of managing the regulatory expectations within and across jurisdictions, and the complexity of applying multiple guidances from pharmaceutical and device development to the combination product.

The DIA 2021 Special Topic: Risk Management in Combination Product Development Conference will focus its efforts on educating attendees about risk management from both an industry and global regulatory perspective, to continue to create the framework for a clear and consistent approach to product development, management, and regulation. This conference will showcase how a risk-based approach can help guide an understanding of ways in which drug and device-led combination product categories may be similar and different, and how these attributes should inform product stewardship and regulation.

This event will provide a space for global stakeholders to virtually gather to solve a complex problem and provide answers to key questions:

• How can we develop a consistent strategy for the application of risk management documents and for clarity of engagement with regulators?
• How can risk management be leveraged across the product lifecycle with an emphasis on premarket considerations from an industry and global health regulator perspective?
• How can case studies from combination product development be applied to assess best practices for industry and regulators considering the relative risk profiles of these categories of products?