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Combination Products Conference

Now offering a preconference Primer on October 14


Session 4: Device Post-Market Safety Management in a Drug Product World

Session Chair(s)

Khaudeja  Bano, DrMed, MD, MS

Khaudeja Bano, DrMed, MD, MS

  • Executive Medical Director, Combination Product Safety Head
  • Amgen, United States
This session will explore end-to-end considerations for implementing post-market safety reporting (PMSR) requirements related to the inclusion of a device constituent part in a drug/biologic combination product. Speakers will discuss industry best practices to overcome key challenges (TPM, outsourcing of case processing, multiple presentations etc.) using a case study for a hypothetical device malfunction scenario in a single entity simple drug delivery system. Next they will outline a risk-based approach to handling device malfunctions, followed by a discussion on the challenges with lifecycle management. Next generation device development will be explored as we ask ourselves how are we doing in the development phase of combination products as an industry. The session will then conclude with Q&A including speakers from the FDA and EMA (EU) for audiences to gain insights on their objectives and plans for additional malfunction data collected in this process.
Learning Objective :
  • Develop an understanding of the role of a device constituent part and its impact to the drug / biologic world of product safety in the context of the new post-market safety reporting (PMSR) requirements for a combination product
  • Successful implementation of the post market safety management process for a combination product
  • Discuss implementation challenges and industry implementation best practices

Speaker(s)

Khaudeja  Bano, DrMed, MD, MS

Speaker

Khaudeja Bano, DrMed, MD, MS

  • Executive Medical Director, Combination Product Safety Head
  • Amgen, United States
Melissa  Burns, MS

Speaker

Melissa Burns, MS

  • Senior Program Manager, Office of Combination Products, OCPP, OC
  • FDA, United States
Keith  Morel, PhD

Speaker

Keith Morel, PhD

  • Vice President Regulatory Compliance | Principal Consultant
  • Qserve Group US, Inc., United States
John Barlow Weiner, JD

Panelist

John Barlow Weiner, JD

  • Associate Director for Policy, Office of Combination Products, OCPP, OC
  • FDA, United States