Drug-device combination products such as prefilled syringes, autoinjectors, etc. can play an important role to ensure patient convenience, compliance, and enhance therapeutic impact of the drug. An integrated control strategy for combination products is critical to ensure that the products are designed, manufactured, and released with the desired product quality and robustness. Building an integrated control strategy starts with a thorough understanding of the materials, components, product design, and the associated processes; this understanding usually begins early during clinical development. The extent of the control strategy should be risk-based and assessed throughout the product lifecycle. This session will cover the following topics: (a) development and implementation of an integrated control strategy throughout clinical development, commercial marketing authorization, and post-approval life cycle management and (b) effective use of design controls framework, prior knowledge, and risk management process to implement an effective control strategy. In this session, the audience will have the opportunity to learn from real-world case studies as well as interact with industry-leading experts and key regulatory opinion leaders.

Session Speakers:

Considerations for Developing an Autoinjector Control Strategy: A Case Study

Kristin Benokraitis, Biogen

Maintaining an Integrated Control Strategy Throughout Combination Product Lifecycle Changes

Amir Tabaian, Pfizer, Inc.

Additional Panelists:

Ben Stevens, GlaxoSmithKline

Chin-Wei Soo, Genentech, a Member of the Roche Group

Wayne Kelley

Appearances

Parallel Session 5A - Integrated Control Strategy for Combination Products

Session Chairs

Speakers