How Safe Are My Combination Products? Regulatory Strategy Lifecycle Management Considerations

26 September 2022 17:25 - 17:55

  • Regulatory Landscape Understanding
  • Product and Usability Development Key Concepts
  • Lifecycle Management QMS Infrastructure Highlights
  • Regulatory Submission Aspects for Complex Products
  • Case Studies – Clinical Trial and Complaint Handing Concepts
Next generation combination products are emerging as innovative medical products due to their contribution in advancing medical care and are expected to have a major impact in the coming years.  Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. The opportunity to work within the combination product space and to work cross functionally with medical device, software, pharmaceutical and biologic experts will be a great experience which will involve a ton of knowledge sharing across the team of experts.  While there are similarities there are also many differences in the development of various combination product therapeutic applications. Overall, the successful development of combination products will require significant collaboration within the industry to overcome regulatory, clinical, technical and lifecycle management challenges.

James Wabby, Global Head, Regulatory Affairs (CoE), Emerging Technologies, Combination Products and Devices, AbbVie