CRO Career Conversations: Project Management Roles in Clinical Research

The North Carolina Biotechnology Center has helped hundreds of companies achieve amazing milestones over four decades. It’s only fitting that the state’s thriving life sciences sector stop and recognize NCBiotech’s own milestone on the 40th anniversary of its founding.

The regulatory strategy for the combination product is critical for guiding activities from development through lifecycle management of combination products. This presentation focuses primarily on the development and refinement of the regulatory strategy and submission planning and execution for drug Primary Mode of Action (PMOA) combination products, which combine a drug or biological product with a medical device. Many of the concepts discussed can also be applied to device PMOA combination products and to drug-biologic combination products. 

Regulatory inspections are crucial to maintaining compliance within regulated industries, especially in the life sciences industry. Given the high stakes of these inspections, organizations must remain compliant.