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CMC Workshop

Explore how to utilize effective CMC strategies and execution and how it can help to reduce regulatory burden, enable shorter review timelines, and support post-approval maintenance.

Session 5 Track C: Combination Products CMC

Session Chair(s)

LeeAnn L Chambers, MS

LeeAnn L Chambers, MS

  • Principal Research Scientist, Global Regulatory Affairs, CMC - Devices
  • Eli Lilly and Company, United States
Combination products represent a unique intersection of drug product and device regulation. Determining how and when to apply the diverse regulations in the design, development, registration, and maintenance of these products is something every Combination Product sponsor needs to consider. This session will include:
  • Regulatory challenges that combination product sponsors commonly face for existing device constituents, such as a change in resin type, a new raw material supplier, or changes to part molds, and how Established Conditions can be used to improve submission strategy and the dossier.
  • The challenges of combination products from the device engineer perspective when developing delivery systems for generic and complex generic drug products including an examination of complying with Combination Products GMP Design Control regulations, determining Design Inputs and Essential Performance Requirements, identifying and addressing Threshold Analysis, Human Factors and Risk Management requirements.
  • The key principles of risk management that apply to combination products and the tools available to perform risk management including examples of the challenges drug companies face when applying these tools. Additional examples will be provided showing how risk management findings are connected to Essential Performance Requirements and reliability.


Diane  Harper, JD, PhD, RAC

Established Conditions for Combination Products

Diane Harper, JD, PhD, RAC

  • Director Regulatory Affairs - CMC, GRACS-MDCP Biologics and Devices
  • Merck, United States
Gary  Henniger

Challenges and Approaches to Generic Combination Product Development from a Device Engineering Perspective

Gary Henniger

  • Sr Director, Global Device R&D Operations
  • Teva Pharmaceuticals, United States
Fubin  Wu

Drug Delivery Combination Product Risk Management: Challenges, Principles, and Best Practices

Fubin Wu

  • Co-Founder
  • GessNet™ Risk Management, United States

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