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In the rapidly evolving landscape of drug delivery, on-body delivery systems (OBDS) continue to stand out as a sophisticated integration of medical devices and pharmaceuticals, collectively referred to as "combination products." These devices provide unique benefits that allow patients to administer large volumes of medicine in the comfort of their home. The additional benefit of a pre-programed OBDS allows for drug administration at predetermined times and dosages with minimal user intervention, thereby supporting patient adherence and, by extension, supporting clinical outcomes.

As technology continues to advance, so does the global regulatory complexity. Due to their dual nature, OBDS must comply with both medical device and pharmaceutical regulatory standards, presenting an inherent complexity for developers. This webinar explores the crucial regulatory requirements involved in the development and approval of these combination products and aims to navigate stakeholders through the regulatory landscape to facilitate successful approval.

Learning Objectives:

  • Gain a comprehensive understanding of on-body delivery systems, including their design, function, and potential impacts on drug delivery practices.
  • Explore the regulatory requirements and frameworks associated with on-body delivery systems, emphasizing the importance of compliance to ensure successful market entry and adoption.

Dr. Di Wu

Manager, Regulatory Affairs

Dr. Di Wu is a regulatory affairs professional with 10 years of experience in the medical device industry, specializing in combination products. She holds a bachelor's degrees in biotechnology from Sichuan University, China, and a Ph.D. in Physiology from East Carolina University, USA. In her current role at West Pharmaceutical Services, she serves as the regulatory lead for multiple design and development projects of the on-body delivery system and successfully supported pharmaceutical partners’ marketing applications for combination products across the United State, Europe and Asia.